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पैंतालिसौं दीक्षान्त समारोहको आवेदन गर्ने म्याद थप सम्बन्धी सूचना |

त्रिभुवन विश्वविद्यालय

परीक्षा नियन्त्रण कार्यालय, बल्खु 

पैंतालिसौं दीक्षान्त समारोहको आवेदन गर्ने म्याद थप सम्बन्धी सूचना 

 

त्रिभुवन विश्वविद्यालयको पैंतालिसौं दीक्षान्त समारोहमा आवेदन भर्ने विद्यार्थीहरुको लागि इलष्लिभ फारम भर्ने म्याद २०७६ साल कार्तिक ८ गतेसम्म थप गरिएकोले सरोकारवाला सम्बन्धित सबैलाई जानकारी गराईन्छ ।  

पुनश्च :

मिति २०७५ साल जेष्ठ मसान्तसम्ममा ट्रान्स्त्रृmप्ट लिईसकेका सम्पूर्ण विद्यार्थीहरुले २०७७ मंसिर मसान्तसम्ममा मूल प्रमाणपत्र (Original Certificate) लिईसक्नु पर्नेछ । अन्यथा सो अवधि पछि अतिरिक्त शुल्क लाग्ने व्यहोरा समेत सूचित गरिन्छ । 

नि.परीक्षा नियन्त्रक

 

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National Guidelines on Prevention, Management and Control of Dengue in Nepal

http://www.edcd.gov.np/resources/download/national-guidelines-of-prevention-control-and-management-of-dengue-in-nepal-2019

Menstrual cycle

The cyclical event  seen in sexually mature female in which there is per vaginal bleeding due to sheding of endometrium because of withdrawl of estrogen and progestrogen

The average menstrual cycle lasts 28 days

Menstrual stage

The first 3 to 5 days of the cycle are characterized by menstrual flow.

There is withdrawal of  hormones due to degeneration of  hormones so constriction of  endometrial arteriole then tissue ischemia and shedding of endometrium which leads to pervaginal bleeding

Proliferative (estrogenic) stage

. Begins during the later stages of menstrual flow and continues through the 13th or

14th day

Ovarian events

There is follicular growth due to stimulation of  FSH . The growing follicle produce estrogen which leads to endometrial change in uterus

Uterine events

Due to action of estrogen there is massive hyperplasia of endometrial cells

Hyperplasia of glands and watery secrection

Endometrium become highly vascularise

As the estrogen level persistently become high it gives positive feedback to hypothalamus which leads to massive release of  LH that leads to release of ovum from the ovary called as ovulation after ovulation graffian follicle changed into corpus leuteum which secrects progesterone and the cycle moves to secrectory phase

Secretory phase

Corpus leutem secrects progesteron which leads to fowling endometrial changes

·        Continues the hypertrophy of the endometrium

·        There is increased vascularity and increased edema.

·        Hypertrophy of  the gland and thick secrection from endometrium

·        Blood vessels become more spiral.

      

     Some remedies for painful mensuration:

1. Hot water therapy
2. Warm bath
3. Light exercise 
4. Balanced diet
5. Some NSAIDS like Mefenamic acid, Ibuprofen etc.

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What is needed to be a Pharmacist ?

To become a well established pharmacist is not a easy job. I am not talking about assistant pharmacy or pharmacy assistant. In this article i am talking about either bachelor degree in Pharmacy, Pharm.D or Master in Pharmacy.

- First you have to determine yourself to be a good pharmacist before starting a course.

- Then you have to choose a college which you like the most and have the well resources throughout your course, please don't choose   college due to accommodation facilities instead choose college according to qualified teaching technique or facilities.

- After choosing the college look all the syllabus and plan accordingly.

- Study harder for exam, if you get failed then please donot loose hope  since it is the subject where more than 60% student passed in re-exam.

- Focus on Practical too.

- Choose which field you want to go after the course.

- Pass the license exam.

- Work in the sector you interested in the most.

- Don't feel frustrating while working.

After certain time of your working you will reach in your destination. you will either

- Pharmaceutical Company Manager

- Hospital Pharmacist

- Clinical Pharmacist

- Professor

- Researcher

But in some country you have to do post graduation as per your interested field like Industrial pharmacy, Clinical Pharmacy, Pharmacology etc.

It is the field not to loose hope, keep patience and keep going. You will reach in the destination as per your actual potential.  

Pharmacovigilance

Definition:

According to WHO Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.

Status of Pharmacovigillance in Nepal

GoN nominated Department of Drug Administration (DDA) in October 2004 as the focal point (National Pharmacovigilance centre) to liaison with WHO collaborating centre for International Drug Monitoring, Sweden and started collecting adverse drug reactions. Nepal became a WHO programme member in July 2006.

At present, there are 12 regional pharmacovigilance centers in Nepal

• Tribhuvan University Teaching Hospital, Maharajgunj
• Civil Service Hospital, Minbhawan
• Manipal Teaching Hospital, Pokhara
• KIST Medical College, Imadol
• Nepal Medical College Teaching Hospital, Jorpati
• Patan Hospital, Lalitpur
• B.P Koirala Institute of Health Science (BPKIHS), Dharan
• Dhulikhel Hospital, Banepa
• Shree Birendra Hospital, Chhauni
• Norvic International Hospital, Thapathali
• Nepal Cancer Hospital and Research Center, Harisiddhi
• College of Medical Sciences - Teaching Hospital

These regional pharmacovigilance centers operate under DDA (DDA being the National centre for ADR monitoring). The regional centers reports ADRs to the National center (DDA) via ‘Vigiflow’ (an online program) which are then forwarded to the Uppsala Monitoring Center (UMC) by the National Centre. The National database contains about 547 ADR reports so far.

औसधिको उचित प्रयोगमा फार्मासिस्ट को आवस्यकता

अलि सम्पन्न मुलुकमा डाक्टरले औसधिको पुर्जा लेखिसकेपछि फार्मासिस्टले प्रमाडित गर्ने गर्छन अनि नर्सेले प्रमारि करण  हेरिसकेपछि बल्ल बिरामीलाई औसधि लगाइदिने गर्दछन। तर हाम्रो नेपालमा येस्तो गर्ने चलन अझै सम्भब नै हुन सकिरहेको छैन, जसका कारण देशमा उत्पन्न भएका क्लिनिकल फार्मासिस्टहरु बिदेसिनु बाहेक अरु केहि विकल्प नै रहेन।  नेपालमा औसधि पसले वाहेक फार्मासिस्ट औसधिको उचित प्रयोग गर्न जानेको एक बीज्ञ  पनि हो भन्ने सोच अझै पनि नेपाली समाजमा विकसित हुन सकिरहेको छैन।  

अत: अझै भन्नु पर्दा कतिपय औसधि हुन्छन जुन बिरामीलाई लगाइदिसकेपछि  तेस्को निरन्तररुपमा सरीरमा केहि toxic  effect देखाउछ कि भनेर जचिरहनु पर्दछ, जुन कुरा फार्मासिस्टले वाहेक अरु ले गर्दैन। औसधिको उचित प्रयोग नहुदा बिरामीको ज्यान  पनि जान सक्छ. तर हामीले रोगले बिरामीको ज्यान गयो कि औसधिको अनुचित प्रयोग ले हामीलाइ  अवागत नै हुदैन।

क्लिनिकल फार्मासिस्टले गर्ने कामहरु-

- औसधि सहि मात्रामा दिए नदिएको जाच गर्ने

- औसधिले adverse reaction गर्छ  कि जाच गर्ने

- औसधिको उचित प्रयोगको लागि अन्य स्वास्थ्यकर्मीलाइ सल्ला सुझाब दिने 

- antibiotic को उचित प्रयोग गर्नका लागि उत्साहान गर्ने

- बिरामीलाई औसधिले केहि नकारात्मक असर गर्यो कि भनेर जाच गर्ने

- लिवर खराब अनि किड्नी खराब भएका  व्याक्तिलाइ डोज पत्ता लगाउने 

देशका दक्ष्य जनसक्ति विदेश मा पलाएन हुनु पर्ने अनि देशका नागरिक औसधिको  अनुचित प्रयोग ले ज्यान गुमाउन  पर्ने अवास्था छ ,अब नेपाल सरकार को  यो कुराको  गम्बिर  ध्यानाकर्सन हुन जरुरि छ।  

- 

Dengue Fever- symptoms, prevention and treatment in Nepal

Dengue fever is going viral nowadays in Nepal basically in Rupandehi dristricts. It is caused by the single bite of infected mosquito infected by dengue virus. It is characterized by dengue kits test and also low platelets counts.

Sign and Symptoms
- High fever upto  104 degree F.
- Headache
- Joints and muscle pain
-Nausea and vomiting
- Anorexia
- Pain of eyelids

Prevention
- Clean the environment, where there high prone of mosquito.
- Use mosquito repellents while sleeping.
Were full cloth while going out.

Treatment
Since this is the viral infection so there are no any specific medicine unless treating its symptoms.
- Paracetamol 500 mg three times a day to control fever.
- antiemetic like domperidone to control nausea and vomiting.
- Oral Re hydration Solution to compensate fluid loss.

Home remedy and foods supplements
- Pomegranate
- Soup
- Apple
- Plenty of water
- Green vegetables
- Liquid containing food
- Coconut water

Since there is no any medicine for dengue virus, unless dangerous symptoms arises like bleeding from nose, mouth, stool and urine, there in no need to hospitalization. if Platelets count falls to the minimum hospitalization is required. 'It takes upto 7 to 14 days to complete recovery.

What is pharmacy ?

Definition:

Pharmacy is the branch of science which deals with  manufacturing, compounding medicine, dispensing with proper counselling and appropriate dosage regimen.

Pharmacy School of Nepal:

-Council for Technical Education and Vocational Training (CTEVT) - diploma in Pharmacy.

- Kathmandu University- bachelor and master in Pharmacy

- Tribhuwan University- Bachelor in Pharmacy

-Pokhara University- bachelor and master in Pharmacy

-Purwanchal University- Bachelor in Pharmacy.

Scope:

 - Hospital

-Clinic

- Industry 

- Academic purpose.

Result of B.pharmacy, B.optometry, BPH, BMLT, BAMS, B.Nursing

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Drug abuse and drug dependence

Definition:
Drug dependence:
When a person loses control over his drug consumption or rather drug consumption control, the person they may be describe as dependence. Drug dependence can present a significant amount of risk and harm to the individual and society. There is a clear association between drug dependence and social deprivation.

Dependence also define as physical or psychological effect produce by the habitual taking of certain drug characterized by a consumption to continue  taking of the drug .

Classification of drug dependence
Generally drug dependence is classified in to two type: Physical dependence: n Withdrawal of the drug causes specific symptom (withdrawal symptom) such as sweating vomiting. Substances that may induce physical dependence include alcohol and hard drug morphine heroin and cocaine.

Psychological dependence 
In this repeated use of a drug induce reliance on it for a state of wellbeing and contentment but there are no physical withdrawal symptom If use of the drug is stopped. Substances that may induce psychological dependence include nicotine  in tobacco, cannabis and many soft drug such as barbiturate and amphetamine.

Drug abuse
Drug abuse is the term commonly use to refer to consumption of psycho active or other drug substances with out medical or health care instruction. Substances used in the place of drug to include non medicinal chemical such as alcohol and nicotine.

The harm related to drug abuse and drug dependence
-Health problem
-Social problem
- Drug related crime

Management of drug abuse and drug  dependence 
-Primary prevention
- Secondary prevention
- Drug education
- Social support
- Rehabilitation
- harm reduction

Role of pharmacist in drug dependence 
Community pharmacist : 
 -Extend opening hour
- Accessibility
- expert advice n Network of service
Hospital pharmacist 
- Admission
- Discharge
-Initiation of substitute therapy

specialist pharmacist :

Thank you…

SUPPOSITORIES AND PESSARIES

DEFINITION

A suppository is a medicated solid dosage form generally intended for use in the rectum, vagina and to a lesser extent, the urethra.

After insertion they melt or soften at body temperature, whereas vaginal suppositories sometimes called as pessaries, are also made as compressed tablets that disintegrate in body fluids .

BP DEFINITION : SUPPOSITORY

 “Suppositories are solid, single-dose preparations . The shape, volume and consistency of suppositories are suitable for rectal administration. ”

BP DEFINITION: PESSARIES

“ Pessaries are single dose preparations . They have various shape usually ovoid with a volume and consistency suitable or insertion into vagina. They contain one or more active substances dispersed or dissolved in suitable basses that may be soluble or dispersible or melt at body temperature . Excipients such as diluents, adsorbents, surface active agents, lubricants, antimicrobial preservatives and colorizing material authorized by the competent authority may be added if necessary. ”

PESSAARIES

Common ingredients for inclusion in pessaries for local action include:

Ø antiseptics Ø contraceptive agents

Ø local anaesthetics

Ø various therapeutic agents to treat trichomonal, bacterial and monilial infections .

Advantages

Oral route not useful.

Patient – GIT problems, Nauseous or post operative.

Very young , very old, or the mentally disturbed.

Drug have GI side effects.

Drug - not stable at GI pH or susceptible to enzymatic attack in the GI tract

Drug - first pass metabolism.

Drugs with 

an unacceptable taste can be administered.

Drug that may be abused as in suicide.

Disadvantages

Mucosal irritation

Traditional Issues feeling of aversion

Leakage 

Sometimes incomplete absorption.

Inter and intra subject variation.

Proctitis .

Large scale production difficult and costly

Shelf life (stringent storage conditions)

.

GI state affects absorption

DOSAGE FORM CHARACTERISTICS:

a. Rectal suppositories for adults weigh 2 g and are torpedo shape . Children's suppositories weigh about 1 gm.

b . Vaginal suppositories or Pessaries weigh about 3 - 5gm and are molded in globular or oviform shape or compressed on a tablet press into conical shape.

c . Urethral suppositories called Bougies are pencil shape. Those intended for males weigh 4 g each and are 100 - 150 mm long. Those for females are 2 g each and 60 - 75 mm in length.

8

d. Nasal suppositories: Called nasal bougies or buginaria meant for introduction in to nasal cavity. •They are prepared with glycerogelatin base . •They weigh about 1 g and length 9 - 10 cm .

e . Ear cones : • Aurinaria and meant for introduction into ear. • Rarely used. • Theobroma oil is used as base .

• Prepared in urethral bougies mould and cut according to size .

SHAPE OF SUPPOSITORIES

THERAPEUTIC USES

v Suppository can be used for local or systemic effect.

v The action depends on nature of drug , concentration and rate of absorption

v Rectal suppository are intended for treatment of constipation and hemorrhoids .

v Suppositories are also administered for systemic action (analgesics, antispasmodics, sedatives & tranquilizers) .

LOCATION OF SUPPOSITORY

FACTOR AFFECTING DRUG ABSORPTION

FORM RECTAL SUPPOSITORY: 1) Physiologic Factor:

The human rectum is approximately

15 -20 cm in the length, when empty

of fecal material; it contains 2 - 3 ml of inert mucous fluid. In

resting state, the rectum is non motile . There is no villa or

microvillus on rectal mucosa .

Physiological factors include:

A) Colonic Content:

When systemic effect are desired from suppository greater absorption may be expected from a rectum that is void than that with fecal matter. An evacuation enema maybe administered before insertion of a suppository.

Diarrhea, colonic obstruction and tissue dehydration influence the rate & degree of drug absorption from rectum.

B) Circulation: Drugs absorbed rectally partially by pass portal circulation, thereby enabling drug destroyed in liver to exert systemic effect. Depending on the height at which absorption occurs at rectum, the drug passes into inferior, middle or superior hemorrhoid veins .

The inferior is nearest to the anus, the upper hemorrhoid vein —> portal circulation .thus it is advisable to keep suppositories in the lower part of rectum . 50% - 70% of drug administered rectally, reported to go directly into general circulation.

C) pH and lack of buffering capacity of the rectal fluid 

Rectal fluids are neutral (pH 7 - 8), have no effective buffer capacity. The barrier separating colon lumen from the blood is preferentially permeable to the unionized forms of drugs, thus absorption of drug would be enhanced by change in pH of the rectal mucosa to one that increase the proportion of unionized drugs .

2.PHYSIOCHEMICAL CHARACTERISTICS

OF THE DRUG:

A)Lipid water solubility of a drug (partition coefficient Ø The lipid water partition coefficient of a drug is important in selecting the suppository base and in anticipating drug release from that base

Ø lipophilic drug, in other word, distributed in a fatty suppository base has fewer tendencies to escape to the surrounding queues fluids .

Ø Thus water- soluble salt are preferred in fatty base suppository. water- soluble base : PEG, which dissolve in the rectal fluids, release both water- soluble and oil- soluble drugs .

B) Degree of ionization: The barrier separating colon lumen from the blood is preferentially permeable to the unionized forms of drugs, thus absorption of drug would be enhanced by increase the proportion of unionized drugs .

19

C)Concentration of a drug in a base:

v The more drugs in a base, the more drug will be available for absorption.

v If the concentration of the drug in the intestinal lumen is above a particular amount, the rate of absorption is not change by further increase in concentration of drug.

v In general, the rate limiting step in drug absorption from suppository is the partitioning of the dissolved drug from the melted base and not the rate of solution of drug in the body fluid.

v Scientists showed that: the rate, at which the drug diffuses to the surface of the suppository, Particle size, and presence of surfaceactive agents are factors that affect drug release from suppositories .

3) PHYSIOCHEMICAL CHARACTERISTICS OF THE BASE AND ADJUVANT:

1)Nature of the Base: Ø Suppository base capable of melting, softening or dissolving to release the drug for absorption.

Ø If the base irritating the colon, it will promote colonic response, lead to increase bowl movement and decrease absorption.

2) Presence ofAdjuvant in Base :

Adjuvant in a formula may affect drug absorption, change the rheological properties of the base at body temperature, or affected the dissolution of the drug.

SPECIFICATIONS FOR SUPPOSITORY BASES :

1 - Origin & Chemical Composition:

A brief description of the composition of the base reveals the sours of the origin (natural or synthetic or modified natural products) . Physical or chemical in- compatibilities with other constituents may be predicted if the exact formula composition is known including preservatives, antioxidants and emulsifiers .

2- Melting Range :

Suppository bases don't have a sharp melting point, their melting characteristics are expressed as ranges, indicating the temperature at which the fats start to melt and the temperature at which completely melted. Melting range is usually determination by " Wiley melting point", "Capillary melting point", Incipient melting (or thaw)point /Softening point.

3 . Solid-Fat Index (SFI):

v One can determine the solidification and melting ranges of fatty bases as well as the molding character, surface feel and hardness of the bases . A base with sharp drop in solids over a short temperature span proves brittle if molded too quickly.

v The solid content at room temperature could determine suppository hardness . Since skin temperature is about 32° C, one can predict that would be dry to touch from a solid content over 30% at that temperature .

4- Solidification Point:

This test allow to determine the time required for solidifying the base, when it is chilled in the mold. If the interval between the melting point and solidifying point is 10°C or more, time required for solidification may have to be shortened for a more efficient manufacturing procedure by refrigeration.

5- Hydroxyl Value: It is the number of milligrams of KOH that would neutralize the acetic acid used to acetylate 1 g of fat. It reflects the mono - and di-glyceride content of a fatty base .

6- Saponification Value: The number ofmilligrams of KOH required to neutralize the free fatty acids and saponify the ester contained in 1 g of a fat. From saponification value we can know the type of glyceride present (mono- , di- or tri-) and also amount present.

7- Iodine Value: It is the number of grams of Iodine that reacts with l00 g of fat or other unsaturated material . The possibility of decomposition by moisture, acids, oxygen (which leads to rancidity of fats) increases with higher iodine value .

8- Water Number: It is the amount of water in grams that can be incorporated in l00g of fat. The "water number" can be increased by the addition of surface- active agents .

9- Acid Value:

It is the number of milligrams of KOH required neutralizing the free fatty acids in 1 g substance (fat) . Low acid value or absence of acid value is important for good suppository bases .

A) Bases B) Antioxidants C) Emulsifying agents D) Hardening agents E) Preservatives F) Thickening agents G) Plasticizer

FORMULATION OF 

SUPPOSITORIES

A) PROPERTIES OF AN IDEAL SUPPOSITORY BASE :

The ideal suppository base may be described as follows : ü Melts at rectal temperature 36°C, or dissolve in rectal fluid. ü Completely non toxic, and non irritating to sensitive and inflamed tissues . ü Compatible with a broad variety of drugs . ü No metastable forms . ü Shrinks sufficiently on cooling to be released form the mold without the need for mold lubricants . ü Non- sensitizing 32

ü Has a melting and emulsifying property. ü Water number is high (a high percentage of water can incorporated in it) ü It is stable on storage, dose not change odor, color, release pattern. ü Can be manufactured by molding either by hand, compression, machine . ü Acid value is below 0 . 2 , saponification value ranges from 200 to 245 , and Iodine value is less than 7 .

Melt at body temp.

Dissolve or disperse in body fluids

Release any medicament readily

Non - toxic & non irritant to mucous membrane

Stable on storage

Compatible with all medicaments

Stable above its melting point

Easily mouldable

Should not adhere to the mould

Properties of an ideal suppository base

TYPE OF SUPPOSITORY BASES :

A- Fatty Bases

B - Hydrophilic Suppository Bases

C-Water dispersible Bases

A. FATTY BASES :

Cocoa Butter (Theobroma oil) It is the most widely used suppository base . It satisfies many requirement for ideal suppository base . 1) Bland. 2) Non reactive . 3) Melt at body temperature .

Ø Cocoa Butter is a triglyceride, yellowish white, solid, brittle fat, smells and taste like chocolate . Ø Its melting point between 30 - 35 ° C, its’ iodine value is “between” 34- 38 . Ø Its acid value is no higher than 4 . Because cocoa butter can melt and become rancid. So it must be stored in cool dry place protected from light. 36

ADVANTAGES

Ø Melting range 30 - 36 0c,easily melts in the body Ø Readily melted on warming, rapid settling on cooling. Ø Miscible with many other ingredients . Ø Non-irritating.

Disadvantages

Polymorphism

Adherence to mould

Low softening point 

Melting point reduction

Deterioration during storage

Poor water absorbing capacity

Leakage from the body

POLYMORPHISM

( the property of existing in different crystalline forms) .

¢ Polymorphism in cocoa butter is observed due to high proportion of unsaturated triglycerides .

¢ The formation of various forms of cocoa butter depends on the degree of heating, on the cooling process and on the conditions during this process .

¢ Each form of cocoa butter has different melting point and drug release rates .

COCOA BUTTER EXITS IN FOUR CRYSTALLINE STATE

α form

• melts at 24oC • Obtained by suddenly cooling melted cocoa butter to 0oC .

ß form

• Crystallizes out of the liquefied cocoa butter with stirring at 18 to 23 oC . • Its melting point lies between 28 and 31 oC .

ß` form

• changes slowly into the stable ß form.

• Melts between 34 and 35oC . • Change is accompanied by volume contraction.

γ form

• melts at 18oC • Obtained by pouring a cool cocoa butter, before it solidifies, into a container which is cooled at deep freeze temp .

Adherence to the mould

Cocoa butter does not contract sufficiently on cooling to loosen the suppositories in the mould.

Sticking may be overcome by adequate lubrication.

Softening point too low for hot climates

To raise the softening point, white bees wax may be added to theobroma oil suppositories intended for use in tropical and subtropical countries .

Melting point reduced by soluble ingredients

Phenol and chloral hydrate have a tendency to lower the melting point of cocoa butter.

So, solidifying agents like beeswax (4%) may be incorporated to compensate for the softening effect of the added substance .

Rancidity on storage:

Due to the oxidation of unsaturated glycerides .

Poor waterabsorbing ability:

Improved by the addition of emulsifying agents .

Leakage from the body:

Sometimes the melted base escapes from the rectum or vagina, so, it is rarely used as a pessary base .

Expensive Relatively high cost

SYNTHETIC FATS

To overcome the disadvantages of theobroma oil synthetic substitutes were searched.

Obtained from hydrogenation and heat treatment to vegetable oils such as palm kernel and arachis .

Hydrogenation saturates unsaturated glycerides and heat treatment splits some of the triglycerides into fatty acid and partial esters (mono and di glycerides).

Most synthetic fat bases are made by first hydrolysing the vegetable oil, then hydrogenating the resulting fatty acids and finally esterifying the acids by heating with glycerol.

Advantages Their solidifying points are unaffected by over heating.

They have good resistance to oxidation because their unsaturated fatty acids have been reduced.

The difference between melting and setting points is small; generally only 1 . 5 to 2oC and seldom over 3 oC . Hence, they set quickly, the risk of sedimentation is low and they are easier to administer.

High softening point grades are advantageous for tropical and sub tropical formulations .

No mould lubricant is needed because they contract significantly on cooling.

They produce suppositories that are white and almost odourless and have very attractive, clean and polished appearance .

Disadvan tages

They should not be cooled in a refrigerator or ice because they become brittle if cooled quickly. Additives such as polysorbate 80 correct this fault.

They are more fluid than theobroma oil when melted and at this stage sedimentation is greater. Thickeners such as magnesium stearate, bentonite reduce this problem.

The release and absorption of drugs in the body may differ for theobroma oil and synthetic bases .

B. HYDROPHILIC SUPPOSITORY BASES:

1 -Glycerine Suppositories(USP): Glycerine 91 g Sod. Stearate 4g Purified water 5g To make approximately l00g

2- Glycerated gelatin suppositories(USP): Drug & purified water 10g Gelatin 20g Glycerin 70g

GLYCERO-GELATIN

This is a mixture of glycerol and water into a stiff jelly by adding gelatin.

It is used for making jellies, suppositories and pessaries and its proportion is changed according to its intended purpose.

Glycero-gelatin dissolves in body secretions and therefore is preferable to a fatty base for administering antiseptics.

Since, solution dissolved slowly, drug release is more prolonged than from fatty base.

PREPARATION OF GLYCEROGELATINE BASES

GLYCEROL WATER GELATINE

GLYCERO-GELATINE BASES

Disadvantages of glycerogelatin base

They have a physiological action (used as laxative)

They are more difficult to prepare and handle.

They are hygroscopic . So a careful storage is required. It also leads to dehydration of the rectal mucosa with consequent irritation; this is an advantage where a laxative effect is required.

MACROGOLS (PEG)

Properties long chain polymers of ethylene oxide with general formula HOCH 2(CH2OCH2)8CH2OH

Exist as liquid if their average molecular range from 200 to 600 and they exist as wax like solid it is above 1000 .

Their water solubility, hygroscopicity and vapor pressure decreases with increase in average molecular weight.

They do not hydrolyse or deteriorate and are physiologically inert and do not support mold growth.

The PEG suppositories can be prepared by both moulding and cold compression methods . 

ADVANTAGES OF MACROGOLS

1.They  have melting point above 42oC. Hence, cool storage is not required, they are satisfactory for use in hot climates, and administration is easy because they are not slippery to handle.

2. Because of this high melting point they do not melt in the body but gradually dissolve and disperse, freeing their medication slowly and providing longer action than fatty bases.

3. Their physical properties can be varied by suitable admixture of high and low polymers. High polymers give hard products that disintegrate and release their drug slowly.

ADVANTAGES OF MACROGOLS

4 . They do not stick to the mould since they contract on cooling.

5 . Because of their high molecular weight solution of high viscosity are produced when they disperse in the body.

6. They absorb water well and have excellent solvent properties.

7. Products have clean smooth appearance.

DISADVANTAGES OF MACROGOLS

a) Hygroscopic:

- Thus can cause irritation to the mucosa .

- This can be overcome by instructing the patient to dip the preparation in water prior to insertion.

b) Poor bioavailability of medicaments - The good solvent property may result in retention of drug in the liquefied base with consequent reduction in the therapeutic effect.

c) Incompatibilities - Incompatibilities with several drugs & packaging materials, e . g benzocaine, penicillin and plastic may limit their use .

d) Brittleness - If cooled too quickly & also on storage .

3 .WATER - DISPERSIBLE BASE :

¢ Several non-ionic surface active materials, closely related chemically to PEG as suppository bases .

¢ The bases can be used for formulation both water- soluble and oilsoluble drugs (e. g.; Tween & Span) .

¢ These surface active agents may be used alone, blended or used in combination with other suppository vehicle .

¢ Another type of water dispersible suppository vehicle is based on the use of water soluble cellulose derivatives (e. g . methylcellulose & Sod. CMC)

ADVANTAGES OF WATER DISPERSIBLE BASES :

1 . Stable on storage at elevated temperature .

2 . Compatible with many drugs .

3 . Non support of microbial growth, non toxic and non sensitive .

(B) ANTI OXIDANTS

v It protect the drugs and bases from getting degraded due to oxidation.

v These are commonly used in all types of suppositories .

EXAMPLES 

v Ethyl or propyl gallate

v Ascorbic acid

v Butylated hydroxy anisole (BHA) v Butylated hydroxy toluene (BHT) v Hydroquinone v Tocopherol

(C) EMULSIFYING  AGENTS

v These increase the water absorbing capacity of fatty bases .

v EXAMPLES

v Poly sorbates (TWEEN 61)

v Wool alcohol

v Wool fats

(D) HARDENING AGENTS

v These are involved in those formulation where the melting point of the bases is decrease by the drugs . v These are the agents which are used to bring the melting point to normal .

v EXAMPLES

v Beeswax

v Macrogols at high molecular weight.

(E)  PRESERVATIVES 

v These are the agents which are used in prevent the growth of microbial in suppository which contains water soluble bases .

v EXAMPLES

v Chorocresol

v Methyl paraben v Propyl paraben

(F) THICKENING   AGENTS

v These are the agents which are used to increases the viscosity of molten bases and prevent sedimentation of suspended in solid bases .

v EXAMPLES

v Aluminium monostearate

v Colloidal silica

v Magnisium stearate v Steary alcohol

(G) PLASTICIZERS

v These are the agent which are used to improved flexibility of suppositories . v It is also used to make the less brittles to suppositories .

v EXAMPLES

v Castor oils

v Glycerine v Glycol

v Tween 80

v Tween 85

METHOD OF MANUFACTURE OF SUPPOSITORIES :

1 - Hand Molding: Ø It is the oldest and simplest method, by rolling the suppository into the desired shape. The mass is then rolled into a cylindrical rod of desire length and diameter.

STEPS INVOLVED IN HAND MOLDING

v The drugs and other additives are made into a fine powder . v It is incorporated into the suppository base by kneading with it or by trituration in a mortar.

v Then these masses are rolled into the shape of a cylindrical rod on the rolling tile in presence of lubricants to prevent the adherence of masses . v Then cut the rods and made one end to pointed.

DRUG+ADDITIVES                           FINE POWDER        

MIXED IN BASES

APPLY LUBRICANTS ON ROLLING TILE

ABOVE MASSES ARE ROOLED IN  CYLINDRICAL SHAPE

CUT THE RODS

PACKED

STORED 

2- COMPRESSION MOLDING:

Ø Elegant suppository can be made compression the cold-grated mass into the desired shape . Ø simple and more elegant appearance than hand molding. Ø Avoids the possibility of sedimentation of the insoluble solids in the suppository base .

v ADVANTAGE

v It is suitable for thermolabile drugs because in this method no heat is required. v Rate ofproduction is more .

v DISADVANTAGE

v The main disadvantage is air entrapment occurs during production so oxidation takes place in suppository.

PROCEDURE

DRUG+ADDITIVES         FINE POWDER

MIXED WITH BASES

LUBRICANTS APPLY IN MOLDS

PLACED THE MASSES IN CYLINDER

APPLY PRESSURE

RELEASE SUPPOSITORY

COOLED       PACKED          STORED

3- Pour Molding (Heat molding) Ø Most commonly used method for production of suppository on both small & large scale . Ø First, the base is melted on water bath, and then the drugs are either emulsified or suspended in it. Then, the mass is pour into cooled metal molds, which are usually chrome or nickel plated.

MELTING THE BASES                          DRUGS

FINE POWDER

TRITURATE  

WITH WARM  WATER

LIQUIDS

MIXED ½ PARTS OF LIQUIDS

MIXING PROPER

ADD REMAINS LIQUIDS

CONT……                   

APPLY THE LUBRICANTS IN MOLD      

OVERFILLING OF MASSESIN MOLDS

REMOVE THE EXTRA MASSES

COOLING (10-15MIN)

OPEN MOLDS 

PACKED

STORED

4 - Automatic Molding Machine: v All the operations in pour molding are done by automatic machines .

v Using this machine, up to about 10,000 suppositories per hour can be produced. v By this the rate of production of suppositories is more higher than hand molding. v In this ,there are no chance of air entrapment and contamination of suppositories . v In this ,if any mass deposited in mold is not removed during cleaning, so produce overweight suppositories with mold marks

There are two types of machines used they are following--(a) Rotary Machinev The rate ofproduction of suppositories are about 3500 - 6000/hr.

v This machine consists of a turn table in which metal molds are fitted.

v This table rotates sequentially, the mold gets filled with drug , additives, bases and cooled and ejects the suppositories . v Before mass filled in mold ,the lubricant are apply in mold wall . v The excess mass is removed by the scraping unit. v The cooling system results the solidification of suppositories . After the cooling the mold is moves towards ejection station , it consists of a stainless steel rod which push out the suppositories from molds .

v Then completed the ejection process , the empty molds are again moves towards the filling unit for further processes . 

DRUG+ADDITIVES                                           FINE POWDER

MELT BASES + POWER

HOPPER

LUBRICATED THE MOLDS

FILL ABOVE  MIXTURE IN MOLD

COOLING SYSTEM

EJECTION SYSTEM

PACKED                   STORED

(B)  LINEAR MACHINE

v It is similar to rotary machine . v Except the rate of production is more higher than rotary machine about 10000/hr.

v All steps involved is similar to rotary machine . v There is no chance of air entrapment and contamination of suppositories as similar to rotary machine . v The rate ofproduction is higher than rotary machine .

PREPARATION OF SUPPOSITORIES MOULDS

SPECIFIC PROBLEMS IN 

FORMULATING SUPPOSITORIES :

1- Water in suppositories: Use of water as a solvent should be avoided:

Reasons :

v Water accelerates oxidation of fats . v If water evaporates, the dissolved substance crystallizes out. v Unless H2O is present at level than that requires for dissolving the drug, the water has little value in facilitating drug absorption. Absorption from water containing suppository enhance only if an oil in water emulsion exist with more than 50% of the water in the external phase .

v Reaction between ingredients (in suppository) are more likely to occur in the presence of water.

v The incorporation of water or other substances that might be contaminate with bacteria or fungi necessitates the addition of bacteriostatic agents (as parabens)

2- Hygroscopicity:

Ø Glycerinated gelatin suppositories lost moisture by evaporation in dry climates and absorbed moisture under conditions of high humidity

Ø PEG bases are also hygroscopic .

3- Incompatibilities:

a- PEG bases are incompatible with silver salt, tannic acid, aminopyrine , quinine , icthammol, asprine , benzoc . aine & sulphonamides . b- Many chemicals have a tendency to crystallize out of PEG, e . g.: sodium sarbital , salicylic acid & camphor. c - Higher concentration of salicylic acid softens PEG to an ointmentlike consistency, d- Aspirin complexes with PEG . e - Penicillin G , although stable in cocoa butter and other fatty bases , was found to decompose in PEG bases . f- Fatty bases with significant hydroxyl values may react with acidic ingredients .

4- Viscosity:

Ø The viscosity of the melted suppository base is important in the manufacture of the suppository and to its behavior in the rectum after melting.

Ø Melted cocoa butter have low viscosity than glycerinated gelatin and PEG type base in low viscosity bases, extra care must be exercised to avoid sedimentation of suspended particles .

To overcome the problems caused by use of low viscosity bases:

a- Use base with a more narrow melting rang that is closer to body temperature . b- The inclusion of approximately 2% aluminum monostearate not only increase the viscosity of the fat base but to maintain homogenous suspension of insoluble material . c - Cetyl , stearyl or myristyl alcohols or stearic acid are added to improve the consistency of suppositories .

5- Brittleness :

Suppositories made from cocoa butter are elastic and don't fracture readily. Synthetic fat base with high degree of hydrogenation and high stearate content and a higher solids content at room temperature are usually more brittle . To overcome : 1) the temperature difference between the melted base & the mold should be minimal .

2) Addition of small amount of Tween 80, castor oil, glycerin imparts plasticity to a fat

6- Volume contraction: Occurs in many melted suppository base after cooling the mold, result in:

Ø Good mold release (contraction facilitate the removal of the suppository from the mold , eliminating the need for mold release agents) .

Ø Contraction hole formation at the open end of the mold, this will lowered suppository . The contraction can be eliminated by pouring a mass slightly above its congealing temperature into a mold warmed at about the same temperature or the mold is overfilled so that the excess mass containing the contraction hole can be scraped off.

Lubricant or mold releasing agent:

Cocoa butter adhere to suppository molds because of its low volume contraction. A various mold lubricants or release agents must be used to overcome this difficulty (mineral oil , aqueous solution of sodium lauryl sulfate , alcohol , silicones , soap) . The release of suppository from damaged mold was improved by coating the cavities with polytetrofluoroethylene (Teflone) .

LUBRICANTS FOR USE WITH 

SUPPOSITORY

BASES:

Base

• Theobroma oil • Glycerolgelatin base

Lubricant

• Soap spirit • liquid paraffin

No lubricant required

• Synthetic fats • Macrogols

7- Rancidity and Antioxidant: Rancidity results from the autoxidation and subsequent decomposition of unsaturated fats into low & medium molecular weight saturated & unsaturated aldehydes , ketones and acids , which have strong unpleasant odor. Example of effective antioxidant are phenols such as " hydroquinone or B naphtholquinone.

DOSAGE REPLACEMENT FACTOR

The amount of base that is replaced by active ingredient in suppository formulation can be calculated. The replacement factor (f) is derived from the following equation: F=100(E-G)+1 Where: E= weight of pure suppository base . G= weigh of suppositories with x% active ingredient.

WEIGHT AND VOLUME CONTROLE:

The amount of active ingredient in each suppository depends on: 1 . Its concentration in the mass. 2. The volume of the mold cavity. 3. The specific gravity of the base. 4. The volume variation between molds (within 2% of the desired value). 5. Weight variations between suppositories due to inconsistencies in the manufacturing process. e.g. incomplete closing of molds, uneven scrapings (variations in weight should be within ± 5%)

EVALUATION OF SUPPOSITORY

¢ Melting range test ¢ Softening time test ¢ Breaking test ¢ Disintegration / dissolution test

1) MELTING RANGE TEST:

¢ Also called the macromelting range test & is a measure of time which takes for entire suppositories to melt when immersed in a constant temperature 37 ◦C water bath.

¢ Micromelting range test is the melting range measured in capillary tubes for fat base only.

¢ The suppository melting point apparatus consist of graduated tube like glass chamber. The sample to be tested is placed in spiral shaped glass test basket inside test chamber i . e . surrounded by water jacket heated by circulation thermostat. Time for the entire suppository to melt or disperse in the surrounding water is measured.

2 . SOFTENING TIME TEST

¢ Softening time test apparatus consists of a U- tube partially submersed in a water bath. A constriction on one side holds suppository in place in the tube . ¢ A glass rod is placed on top of suppository & time to pass through constriction is recorded as softening time i . e carried out at various temp . 35 . 5 - 37 ◦C . ¢ A water bath both cooling & heating elements should be used to assure control within 0 . 1 ◦C . ¢ The penetration tester(PM 30) has been designed to carry out reproducible measurements of softening time of suppository at predetermined temp . ¢ Construction of tester makes visual observation of melting characteristics extremely simple & unit comprises 3 test station. 

3) BREAKING TEST:

Ø It is designed as a method for measuring the fragility or brittleness of suppositories .

Ø The apparatus consists of double-wall chamber in which the test suppository is placed. Water at 37 ◦C is pumped through the double walls of the chamber, and the suppository, contained in the drug inner chamber, supports a disk to which a rod is attached. The outer end of the rod consists of another disc to which weights are applied.

4) DISINTEGRATION DISSOLUTION TESTING:

¢ In an effort to control the variation in mass/medium interface, various means have been employed including wire mesh basket or membrane to separate sample chamber from reservoir. ¢ Sample sealed in dialysis tubing or natural membranes have also been studied.

¢ Flow cell apparatus have been used holding the sample in place with cotton, wire, screening & most recently with glass beads . ¢ The basic suppositories disintegration tester complies with the latest specifications .

PACKAGING OF SUPPOSITORY

¢ Suppository must be placed in a container in such a manner that they do not touch each other.

¢ Staining, breakage or deformation by melting caused by adhesion can result from poorly wrapped packaged suppository. Suppository is foiled in tin or Al paper and plastic .

¢ Over wrapping is done by hand or machine . Many suppositories are not individually, wrapped. In such cases, they are placed into cardboard boxes or plastic containers that have been molded to provide compartment for 6 or 12 suppositories .

IN- PACKAGE MOLDING: A significant advance in suppository manufacturing was the development of automated method for molding suppository, directly in their wrapping materials . This is currently accomplished with either plastic or Al-foil .

*ADVANTAGE OF INPACKAGE MOLDING: 1 . high production rate . 2 . no generation of scraping. 3 . no bulk handling. 4 . maintenance of strict temperature control

STORAGE ¢ Suppository should be protected from heat, preferably stored in the refrigerator

¢ Glycerinated gelatin suppositories should be protected from heat, moisture, and dry air by packaging in well- sealed containers and storing in a cool place.

Displacement value: The number of parts by weight of drug that displaces one part of base .

Calculation of DV:

1. Wt. of 6 CB suppository, WCB 2. Wt. of 6 medicated(40%) suppository, WMS 3. Wt. of drug in suppository, WD = WMS x 40/100 4. Wt. of CB in suppository, WB = WMS – WD 5. Wt. of CB displaced by drug, WDCB = WCB – WB 6. Displacement value, DV = WD /WDCB

Q) Prepare six suppositories each containing 250 mg bismuth subgallate.

ü Quantities are calculated for an excess of two suppositories . Therefore calculate for eight suppositories . ü DV of bismuth subgallate = 2 . 7 ü A l g mould will be used with mould calibration = 0 . 94 .

To calculate the amount of base required, a simple equation is used: Amount of base = (N x y) – (N x D/ DV)

N=8 y = 0 . 94 D = 250 mg = 0 . 25 g DV = 2 . 7

Amount of base required = (8 x 0 . 94) –((8x0 . 25)/2 . 7) = 7 . 52 - 0 . 741 = 6 . 779 9 = 6 . 78 g 100

Calculations for more than one drug:

Calculate the quantities required to make 15 suppositories each containing 150 mg hamamelis dry extract and 560 mg of zinc oxide . A 2g mould, with mould calibration of 2 . 04, will be used. Calculate for 17 suppositories (2 excess) . DV of hamamelis dry extract = 1 . 5 , DV of zinc oxide = 4 . 7 .

Weight of hamamelis dry extract = 17 x 0 . 15 = 2 . 55 g . Weight of zinc oxide = 17 x 0 . 56 = 9 . 52 g . Weight of base = 17 x 2 . 04 - (2 . 55/1 . 5 + 9 . 52/4 . 7) = 34 . 68 (1 . 7 + 2 . 03) = 30 . 95 g .

THANKS

14Th licence pharmacy assistant result published

Out of about 420 candidate only 86 are able to make published their name.

१४ फार्मसिस्ट लाइसेन्स परिक्षा को नतिजा प्रकाशित

मिति २०७६/०६/०३ गते भएको फार्मासिस्ट लाइसेन्स परिक्षा मा जम्मा २६% विद्यार्थी उतिर्ण भएका छन। ६४६ जना मध्ये १६८ बिद्यार्थी सफल भएका हुन ।

List of banned drugs in Nepal

Government of Nepal has banned the folowing medicines for production,
sale-distribution and import (oral and parenteral use) on 2040/3/13

 Amidopyrin and its combinations.
 Phenacetin and its combinations.
 Clioquinol and its combinations.
 Combination of vitamins with tranquilisers and / or anti-inflammatory agents.
 Combination of antispasmodic atropine wth analgesics and antipyretics.
 Combinations of yohimbine and / or strychnine with testosterone and / or vitamins.
 Combinations of iron with strychnine and / or yohimbine and / or arsenic.
 Combinations of sodium bromide or chloral hydrate with other drugs.
 Combinations of antihistamines with antidiarrhoels or with antiamoebic.
 Combinations of vitamins with analgesics.
 Combinations of penicillins with sulfonamides.
 Combinations of vitamins C with tetracycline.
 Combinations of steroids with other drugs except with ephedrine and xanthines.
 Combinations of chloramphenicol except in combination with streptomycin.
 Combinations of vitamins with antitubercular drugs except in combinations of antitubercular drug isoniazide with vitamin B6.
 Combinations of ergot except with caffeine.
 Combinations of strychnine and / or caffeine in tonics.

2. Government of Nepal has banned oral rehydration salts for production,
sale-distribution, storage, transportation and import/ export on 2043/2/19 which are not composed according to WHO's formula.

Composition : (gm/litre) as recommended by WHO
Sodium chloride 3.5 gm 3.5 gm
Potassium chloride 1.5 gm 1.5 gm
Sodium bicarbonate 1.2 gm OR -
Trisodium citrate (dihydrate) - 2.9 gm
Glucose 20.0 gm 20.0 gm

3. Government of Nepal has banned the following medicines for
production, sale-distribution, storage, transportation and import/export
on 2047/8/3. The ban should not be applicable to the veterinary products
and topical preparations.

 Oxyphenbutazone and Its Combinations.
 Phenylbutazone In Combination with other Drugs.
 Sulphaguanidine and Its Combinations.
 Tetracycline Liquid Oral Preparation
 Methapyrilene and Its Combinations.
 Nialamide and Its Combinations.
 Practolol and Its Combinations.
 Alcofenac and Its Combinations.
 Methaqualone and Its Combinations.
 Benoxaprofen and Its Combinations.
 Pipradrol and Its Combinations.
 Nitrofural and Its Combinations.
 Chlornaphazine and Its Combinations.
 Chlorphentermine and Its Combinations.
 Cloferex and Its Combinations.
 Diendestrol and Its Combinations.
 Hexextrol and Its Combinations.
 Xenazoic Acid and Its Combinations.
 Aminores and Its Combinations.
 Aristolochic Acid and Its Combinations.
 Santonin and Its Combinations.
 Azaribine and Its Combinations.
 Amphetamine and Its Combinations.
 Phenformin and Its Combinations.
 Diphenoxylate and Its Combinations in Liquid Dosage Forms.
 Lopermide and Its Combinations in Liquid Dosage Forms.
 Combinations of Narcotic Drugs Except the Following:
a) Combinations Containing Pholcodine and Codeine and their Salts as Cough Sedative.
b) Combinations of Codeine with Paracetamol and/or Aspirin in Ratio not Exceeding 1 : 50.
c) Combinations Containing an Antispamodic.
 Combination of Antipsychotic Drug (Neuroleptic) with Other Drugs Except with Anticholinergic Trihexyphenidyl.
 Combination of Antispamodic with Vitamin, Mineral and/or Enzyme.
 Combination of Antacid with Vitamins or Anti-Inflammatory Drugs.
 Combination of Antidiarrhoeal/Antibacterial with Electrolytes.
 Combination of Antitussive with an Expectorant in Cough syrup.
 Combination Containing Two or More Antihistamines.
 Combination of a Hormone with Vitamin.
 Combination of Disodium Hydrozen Citrate with Other Drugs.
 Combination of Ginseng with Modern Drugs.
 Combination of a Bronchodilator with Analgesic or Antipyretic.
 Combination of Cyproheptadine with Strychnine.
 Combination Product Containing Active Ingredients of Two or More Systems of Medicine (e.g. Ayurvedic, Allopathic, Unani, Homeopathic).
 Oral Liquid Vitamins, Vitamin - Enzyme/Vitamin - Amino Acid/Vitamin - Mineral, which do not Contain Vitamin in Therapeutic Dose as per Indian Drugs and Cosmetic Act (Volume not Exceeding
250 ml).
 Combination of Two or More Antibacterials Except the Following:
a) Combination Used for the Treatment of Tuberculosis.
b) Combination Used for the Treatment of Leprosy.
c) Combination of Two Antibiotics of the Penicillin Group.
d) Combination of Two or More Therapeutic Agents as Recognised by Standard Pharmacopoeia (as per the Rule No. 5 Appendix 1 of Star Niyamabali 2043 (Regulation on Standard of Drugs).
Therapeutic dose for vitamin based multi ingredient vitamin or tonic preparations. Vitamin unit preparations containing vitamins for Therapeutic use
a) Liquid (Pack size not exceeding 250ml); in single dose of 5,10 or
15ml; or maximum 30ml in daily divided dose of two to three
times each in a multiple of 5ml.
b) Tablet/capsule
One tablet / capsule maximum up to 3 times a day.
Adult Paedatric
Vitamin A, I.U not less than 5000 & not more than 10000 not less than 1500 & not more than 5000
 Vitamin D, I.U not less than 400 not less than 100 and not more than 1000 & not more than 400
Vitamin B1 mg not less than 4.5 & not more than 10 not less than 1 & not more than 4.5
Vitamin B2 mg not less than 5 & not more than 10 not less than 1 & not more than 5
Vitamin B6 mg not less than 1.5 & not more than 3 not less than 1 & not more than 3
Niacinamide mg not less than 45 & not more than 100 not less than 10 & not more than 4
 d-panthenic mg acid or its salts & Panthenol, mg not less than 5 & not more than 50 not less than 2.5 & not more than 10
Folic acid mcg not less than 1000 & not more than 1500 not less than 100 & not more than

500
Vitamin B12 mcg not less than 5 &
not more than
15
not less than 1 &
not more than 5
Vitamin C mg not less than 75
& not more than
150
not less than 30 &
not more than 80
Vitamin E I.U not less than 15
& not more than
25
not less than 5 &
not more than 20
1. Vitamins intended for therapeutic use shall bear on the label the words
"for therapeutic use-adult 'or' for therapeutic use-paediatric" as the case
may be.
2. The above standards shall not be applied to any preparation containing
single vitamin only & also to any preparation containing vitamins
intended for parenteral use.
4. Government of Nepal has banned the folowing medicines for
production, sale-distribution, storage, transportation and import/export.
The ban should not be applicable to the veterinary products and topical
preparations on 2049/11/18
 Codeine or codeine based cough syrup except cough Syrup containing
single codeine (active ingredient) 3 mg/5ml in a bottle not exceeding
60ml.).
 Combination of any antibacterial with another drug except the
following
a) Combination used for the treatment of tuberculosis
b) Combination used for the treatment of Leprosy
c) Combination of two antibiotics of the penicillin group
d) Combination of two or more therapeutic agents of antibacterial
group included in Pharmacopoeia, recognised as per the
regulation on standards of drugs 2043, rule 5, appendix- 1)
3. Streptomycin in oral dosage from
4. Combination of Paracetamol or Aspirin except in the following
a) Combination of Paracetamol or Aspirin with one nasal decongestant
and one antihistamine
b)
Combination of Paracetamol or Aspirin (not exceeding 500mg) with
codeine not exceeding 10mg in a tablet)
c) Combination of Paracetamol either with Ibuprfen or with one muscle
relaxant
d) Combinations of Paracetamol or Aspirin with another drug, those are
included in Pharmacopoeia recognised as per the Regulation on
Standards of Drugs 2043, rule 5, appendix - 1
5. Meprobamate or its combination
6. Combination of anti-amoebic or anti-diarrhoeal drug except the
following
a) Combination of Metronidazole or Tinidazole with Diloxanide
furoate
b)
Combination of diphenoxylate 2.5mg with Atropine 0.025mg in a
tablet
7. All combinations of antiflatulant except with antacid or antispasmodic
8. Combination of cyproheptadine with another drug
9. All multi-ingredient based vitamin or Tonic preparations except the
following
a) Vitamin product in therapeutic dose as denoted in appendix-1 of
this notice
b)
Therapeutic B-complex based product (Appendix-1) containing
enzyme & / or aminoacid or protein or mineral)
c)
Combinations, of vitamin in therapeutic dose with another drug,
that are included in pharmacopoeia, recognised as per the
regulation on standards of drugs 2043.
Note: The following amendments have been made on the above ban list on
2050/9/5.
1. The statement on 4(a) of the above notice has been defined as "
Combination of paracetamol or aspirin with one decongestant and / or
one antihistamine."
2. The following catagories of formulations will be exempted from the
provision of 9 of the above notice.
5. Government of Nepal has banned the following medicines for
production, sale-distribution, storage, transportation and import/export
on 2054/4/16. The ban should not be applicable to the veterinary products
and topical preparations.
1. Liquid preparations containing sodium bicarbonate intended for use in
children.
2. Analgin (Metamizole) and its combinations