Pharmaceutical Dosage Forms I Course Outline PDF

Pharmaceutical dosage forms I By Taher Mohamed Yassen Ibrahim Mousa  Basic Information: Course data Course Code: PT203 Course title: Pharmaceutical dosage forms I Academic year: second Level/ third Semester Program title: Doctor of Pharmacy (Pharm...

Pharmaceutical dosage forms I By Taher Mohamed Yassen Ibrahim Mousa  Basic Information: Course data Course Code: PT203 Course title: Pharmaceutical dosage forms I Academic year: second Level/ third Semester Program title: Doctor of Pharmacy (Pharm D-Clinical Pharmacy) Teaching hours/week/semester: 4 hour Lecture: 2 hour/ week (2 credit hour) Practical: -- 2 hours/ week (1 credit hour) Total credit hours :3 hours 2-Professional information 2.1- Overall aims of course Upon completion of this course the student will be able to: Utilize information regarding the system of weights, measures, mathematical expertise and pharmaceutical calculations requisite to the compounding, dispensing and utilization of drugs in pharmacy practice. Employ good laboratory practice in compounding of liquid dosage forms. Respond to different prescription orders. Outline all manufacturing formulation aspects, packaging, storage, and stability of liquid dosage forms including solutions (aqueous and non- aqueous), suspensions, emulsions, colloids and extracts with emphasis on the technology and pharmaceutical rational fundamental to their design and development. Consider the incompatibilities occurring during dispensing are also considered. Work collaboratively and share therapeutic decision-making as a member of a team. Work as a life-long learner for continuous professional improvement and demonstrate capabilities of performance appraisal and self- assessment. 2.2- Intended learning outcomes of course (ILOs) DOMAIN 1- FUNDAMENTAL KNOWLEDGE Upon successful completion of this course, the students should be able to 1.1.1.2. Discuss the principles of pharmaceutical dosage forms 1.1.2.1 Employ the proper pharmaceutical and medical terms, abbreviations, and symbols in pharmacy practice. 1.1.3.1 Consolidate pharmaceutical information from fundamental sciences to allow proper handling, identification, extraction, design, preparation, analysis, and quality assurance of natural and synthetic pharmaceuticals. 1.1.5.1Utilize the information from basic sciences during decisions making and problems solving. DOMAIN 2: PROFESSIONAL AND ETHICAL PRACTICE 2-2 COMPETENCY Upon finishing the course, the student will be able to standardize pharmaceutical materials, formulate, and manufacture pharmaceutical products, and participate in systems for dispensing, storage, and distribution of medicines. 2.2.3.1 Apply the standard pharmaceutical laboratory procedures using different instruments and analytical techniques for synthesis and analysis of various pharmaceutical products 2.2.4.3 Identify and overcome different physical, chemical, and therapeutic incompatibilities that may occur during drug manufacture and dispensing. 2.2.4.4 Formulate of new, safe, and effective drug delivery systems relying on the principles of pharmacokinetics, bio-pharmaceutics, bioinformatics, and pharmacogenomics, biostatistical analysis, bioinformatics. 2-3- COMPETENCY Handle and dispose biologicals and synthetic/natural pharmaceutical materials/products effectively and safely with respect to relevant laws and legislations. DOMAIN 4: PERSONAL PRACTICE 4-1- COMPETENCY Express leadership, time management, critical thinking, problem solving, independent and team working, creativity and entrepreneurial skills. This competency will be developed via the following key elements 4.1.2-2 Implement strategies depending on gathered information from different sources to promote critical thinking, problem-solving and decision-making abilities and resolve conflicts in a manner that supports collaborative work.  Introduction Pharmaceutics include dispensing and pharmaceutical technology. Dispensing is the supply of medicine to patient according to a prescription. Dispensing involves clarification of the prescriber`s wishes, preparation and labelling the medicine. Dispensing includes the art of compounding and utilizing information. Pharmaceutical technology involves the technology necessary for formulation and preparation of dosage forms. Dosage forms are the mean by which drugs are delivered to the site of action within the body. They can be classified according to the route of preparation or according to their nature.  Routes of administration of drugs A- Those intended for systemic effect - Oral route: Involves administration of drug orally to be absorbed in the gastrointestinal tract (GIT). It is the most common. Convenient for self-administration. Suitable for most drugs except those that are rapidly inactivated in GIT. Drugs may be degraded by the stomach pH or by digestive enzymes. Not suitable in case of vomiting or unconscious. Absorption is slow and may be incomplete. Problems from first pass effect. -Buccal and sublingual route: Inhalational route: Involves administration of drug into the buccal cavity or Involves administration of the drug into under the tongue. respiratory system by inhalation. Can avoid some of the problems of oral route. The high blood flow and large surface area of the alveoli provide a route for rapid absorption Very rich with blood capillaries providing rapid drug of drugs. absorption This route is useful for anaesthetic gases, Absorbed drugs reach the systemic circulation avoiding the volatile liquids and drugs that can be dispersed first pass effect. in aerosol form. -Rectal route: The nasal mucosa can also be used as a route Involves insertion of the drug into the rectum. for systemic administration (NASAL route) The drugs are absorbed mainly to the systemic circulation. This route is useful for drugs known to cause GI irritation. It is also useful for comatosed patient or in case of vomiting. Transdermal route: Parenteral route: Involves absorption of the drug into the Involves administration of the drug by injection. systemic circulation after application of the Intravenous route (i.v.) delivers the drug into the drug on the skin. circulation. Useful for drugs that have short half-life (t1/2) Injection volume varies from a fraction of ml up to 500ml. Only suitable for potent drugs Drugs can be absorbed rapidly after intramuscular (i.m) injection of aqueous solution. Slower absorption can take place after subcutaneous injection (s.c.). Other parenteral routes include: Intra-articular (into joints), Intraocular (into eye), Intracardiac (into the heart) and intracisternal (into C.S.F) B- Those intended for local effect -Oral route: In this case drug absorption is not required. This includes drugs which can exert local action on the GIT such as adsorbents, antimicrobials and antacids. -Topical route: In this case drug is applied to the epithelium covering the body. Provides local action at the site of application. Includes dosage forms applied to skin, cornea of the eye, the nasal, rectal, vaginal or urethral mucosa.  Pharmaceutical calculations 1-WEIGHTS AND MEASURES There are two systems of weights and measures: a- Common system (Imperial system). b- Metric system. A- Common system: It's old system based on unrelated units. - It's divided into two systems :1- Apothecaries system. 2- Avoirdupois system. B- Metric system Formulated in France in the late of eighteenth century. Because of it's easier calculations, greater accuracy, and flexibility, it's the most widely used system for calculation. However some physicians are still using imperial systems in prescribing drugs, so it's still necessary to the pharmacist to be familiar with both systems  A- Common system 2- Avoirdupois measure of weight : 1- Apothecaries system 2- Avoirdupois system 437.5 grains (gr) = I ounce (oz) 16 oz (7000 gr ) = 1 pound (lb) a- Apothecaries fluid measures:- b- Apothecaries measures of weights: 60 minims (ɱ) = 1 fluiddrachm (fʓ ) or (ʓ ) 20 grains ( gr ) = 1 scruple (℈ ) 8 fʓ (480 m ) = 1 fluidounce (f ℥ ) or (℥ ) 3 (℈ ) ( 60 gr) = 1 drachm (ʓ ) 16 f ℥ = 1 pints (pt.) or ( O ) 8 ʓ (480 gr ) = 1 ounce (℥ ) 2 O (32 f ℥ ) = 1 quart (qt.) 12 ℥ (5760 gr ) = 1 pound ( lb) 4 qt (8 O) = 1 gallon ( gal. ) or (C ) Relationship of avoirdupois and apothecaries Example Convert ℥ ii, ʓ ii to avoirdupois weight. weights Answer The grain is the same in both systems, but other ℥ ii = 2 x 480 gr = 960 gr ʓ ii = 2 x 60 gr denominations with the same name are not equal. = 120 gr Total = 1080 gr. To convert from either systems to the other, first In avoirdupois system reduce the given quantity to grains in the one system, and then reduce to any desired denomination in the oz ------------ 437.5 gr other system. X ------------ 1080 gr X= 1080 / 437.5 = 2.4685 oz 2 oz & 205 gr.  B- Metric system 1. Measure of length 2 - Measure of volume 3- Measure of weight The meter is the fundamental unit of The liter is the fundamental unit of Gram is the fundamental unit of this system this system metric system 1 kilometer (km) = 1000 meters 1 kiloliter (kl) = 1000 L 1 kilogram (kg) = 1000 g 1 hectometer (hm) = 100 meters 1 hectoliter (hl) = 100 L 1 hectogram (hg) = 100g 1 dekameter (dam) = 10 meters 1 dekaliter (dal) = 10 L 1 dekagram (dag) = 10 g 1 decimeter (dm) = 0.1 meter 1 deciliter (dl) = 0.1 L 1 decigram (dg) = 0.1 g 1 centimeter (cm) = 0.01 meter 1 centiliter (cl) = 0.01 L 1 centigram (cg) = 0.01 g 1 millimeter (mm) = 0.001 meter 1 milliliter (ml) = 0.001 L 1 milligram (mg) = 0.001 g 1 micrometer (µm) = 0.000001meter 1 microliter (µl) = 0.000001 L 1 microgram (µg) = 0.000001 g 1 nanometer (nm) = 0.000000001 1 nanogram (ng) = 0.000000001 g meter  Relation of metric to other systems of measurement 1 – Equivalents of length 3- Equivalents of weights 1 inch = 2.54 cm 1 gr = 0.065 g or 65 mg ( i.e 1 gm = 15 grain ) 2 – Equivalents of volume 1℥ =30 g 1 ɱ = 0.06 ml ( i.e 1 ml = 16 ɱ ) 1ʓ=4g 1 fʓ = 3.6 ml 1 lb = 454 g (avoirdupois system), 2.2lb=1kg. 1 f ℥ = 30 ml I lb = 373 g (apothecary system), 2.74lb= 1kg 1 pt. = 473 ml 1 qt. = 946 ml 1 gal = 3785 ml  House Hold units According to the USP, in calculating doses, the pharmacist and physician can accept the 4 ml (1f ʓ) for 1 teaspoonful 8 ml (2f ʓ) for 1 dessertspoonful 15 ml (4f ʓ) for 1 tablespoonful 30 ml (1 fƺ) for 1 coffecupful 60 ml (2fƺ) for 1 wineglassful 120 ml (4 fƺ) for 1 teacupful 240 ml (8 fƺ) for 1 tumblerful  Example 1 Example 3 Reduce ℥ ss ʓ ii ℈ I to grains. A pharmacist had 1 gallon of alcohol. At different times he dispensed f℥ IV, Oii, f℥ viii, and fʓ IV. What volume of Answer alcohol was left in liter? ℥ Ss =1/2 x 480 gr.= 240 gr. ʓ ii = 2 x 60 gr= 120 Answer gr. f℥ IV = 4 f℥ , Oii = 2 x 16 = 32 f℥ , f℥ viii = 8 f℥ ℈ I = 1 x 20 gr. = 20 gr. Total = 380 gr. fʓ IV = ½f℥ Example 2 Total = 44 ½ f℥ total dispensed Change 165 grains to weighable apothecaries’ units. 1 gal. = 128 f℥ Answer The lest =128 f℥ – 44 ½ f℥ = 83 ½ f℥ Beginning with the largest we find that we may 83 ½ f℥= 83 ½ x 30 ml = 2505 ml =2.5 liter use the following weights: ʓ ii, ʓ ss, ℈ ss, 5 gr Check: ʓ ii (120 gr) + ʓ ss (30 gr) + ℈ ss (10 gr) + 5 gr = 165 gr. Example 4 Convert 15 kg to pounds avoirdupois Example 5 Convert 2.5 L to fluidounces Answer 2.2 lb = 1 kg X = 15 kg X = 33 lb Answer 1 f ℥ = 30 ml X = 2500 ml X = 84.5 f ℥  Pharmaceutical Calculations Working from master formula (MF). You need to calculate the dispensing factor (D.F). D.F. = (amount required/total amount in MF) 1. Calculate the amount of ingredients required for 150ml opium squill linctus Master formula D.F. = 150/900 = 1/6 R/ Required amounts Squill oxymel ……… …... 300ml Squill oxymel = 300x 1/6 = 50 ml Comphorated opium Tr … 300ml Comphorated opium Tr =300 X 1/6 = 50ml Syr. Tolu ……………….. 300ml Syr. Tolu = 300X 1/6 = 50ml 2. Calculate the amount of each ingredients required to prepare 200ml of chloral hydrate mixture Master formula D.F. = 200/10 = 20 Required amounts R/ Chloral hydrate……… …... 2 g Chloral hydrate = 2 g X 20 = 40 g Syrup ………………….… 2 ml Syrup = 2 ml X 20 = 40ml Water to 200 ml Water to..……………….. 10 ml 3. Calculate the amount of each ingredients D.F. = 30/1000 = 3/100 required to prepare 30g of the following ointment Required amounts Master formula Bees wax =20 g X 3/100 = 0.6 g R/ Hard paraffin = 30 g X 3/100 = 0.9 g Bees wax …..……… …... 20 g Hard paraffin …….… 30 g Cetostearyl alcohol = 50 g X 3/100 = 1.5 g Cetostearyl alcohol …….. 50 g Soft paraffin=900 gm X 3/100= 27 g Soft paraffin ……. ….. 900 g 4. Using the following master formula for a paste, calculate the amounts required to prepare 25g of the paste D.F. = 25/100 = 1/4 Master formula Required amounts R/ Coal tar = 6 g X 1/4 = 1.5 g Coal tar …..……… …... 6 g Starch = 20 g X 1/4 = 5 g Starch … ……….… 20 g Zinc oxide = 20 g X 1/4 = 5 g Soft paraffin = 54 g X 1/4 = 13.5 g Zinc oxide …………….. 20 g Soft paraffin ……. ….. 54 g