Pharmaceutical Formulation Study Materials

1. what is a drug? API is a chemical compound with pharmacological effect for uses of diagnosis, treatment and prevention 2. why cant the API normally given in small quantities be given alone? tablets any smaller would be difficult to manufacture 3. pharmaceutical formulation mixture of API and excipients excipients- ingredients that don't show pharmacological effect- pharmacologically inert 4. dosage form physical form of API given to patients choice of dosage form dependant on APIs physical and chemical properties 5. routes of admin- GI tract istration- enter- first pass metabolism al(oral) pros-non invasive, modified for extended release, convenient, less expensive cons-time for absorption and distribution, discomfort, nausea, sublingual buccal tablets may not be taken properly 6. oral dosage forms- powders bulk powders-solid, loose and dry particles. one or more API. non potent medication gets mixed with water divided powders-sachets granules 7. oral dosage forms-tablets some drugs(paracetamol) cannot be compressed into smaller forms bitter tasting 8. excipients for tablets filler/diluent- increases size of tablet. API is too small binder-makes stronger tablet to resist compression disintegrant- helps tablet to be broken down into smaller fragments glidant-improves flowability of tablet, prevents lumps anti-adherent-stops powder from sticking to surfaces lubricant-smooth surface to reduce friction colourant- distinguish from other tablets, manufacture purposes flavouring 1/4 9. types of tablets disintegration tablets sublingual-under tongue buccal-between cheek and inner lining of the mouth effervescent enteric-stabilizes tablets from rapidly degrading in the stomach chewable lozenges film coated tablets vaginal tablets 10. capsules API and some excipients enclosed in a shell(gelatine) very efficiently maufactured compared to liquid dosage forms 11. liquid oral dosage forms-solution API dissolved in a suitable vehicle(water) clear and does not have any precipitate change in colour- drug degradation and microbes pros- less Gi irritation, absorbed faster than solid cons- microbial contamination, hydrolysis of API in aqueous solution, unpleasant taste 12. liquid oral dosage form-emulsions stabilised oil in water dispersions phases may contain solids re dispersed after shaking 13. liquid oral dosage forms-suspensions useful for adminstering insoluble or poorly soluble drugs 14. liquid oral dosage formssyrups sugar in water-simple syrup with one or more API flavouring syrups coughs, sore throats 15. liquid oral dosage formselixirs potent or unpleasant tasting drugs high proportion of sweetening agent 2/4 16. liquid oral dosage formslinctus demulcent- forms soothing film over mucous membrane, relieving minor pain 17. parenteral administrationpros and cons pros- doesn't pass through GI tract, fast drug action, used for unconscious patients cons- invasive, painful, introduce bacteria to system 18. parenteral administering drug through vein administration-in- fastest route of administration travenous pros-fast acting, immediately available to body cons- recovery is more difficult after error, requires cannula which can be prone to infection 19. parenteral -intra- direct injection into muscle mass muscular can be solutions or suspension 20. parenteral administrationsubcutaneous injecting small amount of solution or suspension immediately under the skin e.g:insulin pro-self taught cons- difficult for patients with thin skin 21. intradermal adminstration injected on top layer of skin- allergy injections 22. intra-articular ad- injecting straight into a joint-knee cap ministration 23. intracardiac adminstration directly to heart muscle 24. intra-peritoneal injecting in abdomen-injecting antibiotics 25. intravitreal administration inside the eye 26. inhale dosage forms-metered dose inhalers standard inhalers normally used for respiratory problems 3/4 27. nebuliser/atomiser liquid mist to airways only used for emergency respiratory problems 28. transdermal patches releases drug over period of time avoids first pass metabolism 29. rectal supposito- dissolves after insertion ries local or systemic effects 30. rectal dosage forms-enemas liquids into rectum and colon evacuant enema-bowle stimulant for constipation retention enema 31. vaginal dosage local effect forms-supposito- moulded pessaries-cone shaped ries or pessaries compressed- made by compression like tablets vaginal capsules-soft gelatin capsul 32. Biopharmaceutics Classification System class I- high permeability, high solubility class II- high permeability, low solubility class III- low permeability, high solubility class IV-low permeability, low solubility 33. a drug is consid- greater than >90% absorption of drug within 90 mins ered to be highly permeable when: 34. a drug is consid- when highest dose is dissolved in less than <250ml of ered to be highly water of water between 1 and 7.5 soluble when: 35. a drug is consid- more than >85% of drug is dissolved within 30 mins ered to be rapidly dissolving when: 4/4