Pharmaceutics Introduction Chapter 1

I. Concepts and tasks A.concepts (1)pharmaceutics basic theory formulation design drug product preparation techniques quality evaluation correct application

(2)dosage forms forms of administration e.g. tablet, capsule, injection, granule… (abstract) (3)pharmaceutical preparations drug+form e.g. aspirin tablets, 0.5%glucose infusion… (objective)

(4)pharmaceutical manufacturing the process of research and preparation of drug product (verb.) (5)drug delivery systems (DDS) modern dosage forms e.g. sustained or controlled; targeting; transdermal; solid dispersion; liposomes; microencapsulation…

B.Tasks to prepare safe, effective, stable and convenient pharmaceutical preparations (1)basic theory (2) dosage forms(esp. Chinese traditional medicine and biomedicine) new preparation techniques excipients equipment(sealed, effective, multifunction, automation and continuity)

II. Branches industrial P.—essential physical P. biopharmaceutics basic P. pharmacokinetics polymers in P. clinical P. hospital P. dispensing P.

III. Dosage forms A.Importance (1)Change the applicative properties of drug (2)Adjust effective time (3)Decrease the side effects of drug (4)Improve targeting ability (5)Affect effectiveness

B. Types (1)According to administration routes gastrointestinal tract (GIT): oral injection (IM, IV, SC…) inhale parenteral transdermal transmucous membrane (buccal, sublingual…) cavity (rectal, ear, nose, vaginal…)

(2)according to dispersion systems solution(molecule or ion) colloid(D:1~100nm) emulsion(insoluble liquids) suspension(insoluble solid and liquid) gas dispersion(aerosol) solid dispersion(solid preparations) microparticle dispersion

(3)according to drug states liquid gas solid semi-solid

C. Development 1 st generation: traditional 2 nd generation: sustained or prolonged 3 rd generation: controlled 4 th generation: targeting

IV. Related statutes A.Pharmacopoeia: standard of medicine Chp 2005 edition(three parts) B. Prescription drug: prescripted by doctors Nonprescription drug (over-the-counter, OTC): mainly chosen and bought by patients themselves

C. Seven “G”s GMP (good manufacturing practice) --enterprise GLP (good laboratory practice) --research institute GCP (good clinical practice) --hospital GSP (good supply practice) --pharmaceutical company GPP (good preparation practice) --hospital GAP (good agricultural practice) --Chinese traditional medicine GUP (good using practice) --using process in hospital (pharmacy, storeroom)

V. Gap between domestic and abroad A.basic theory B.new preparation and technique C.promising excipients D.advanced equipment challenge but a lot of room for improvement!

VI. References 《药剂学》第五版教材 《药剂学》第四版教材 美国《 Modern Pharmaceutics 》 3 rd edition 陆彬《药物新制剂新技术》第一版 中国药科大学《药剂学》第三版