Pharmaceutics

IntroductionChapter 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

1st generation: traditional

2nd generation: sustained or prolonged

3rd generation: controlled

4th 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”sGMP (good manufacturing practice) --enterpriseGLP (good laboratory practice) --research instituteGCP (good clinical practice) --hospitalGSP (good supply practice) --pharmaceutical companyGPP (good preparation practice) --hospitalGAP (good agricultural practice) --Chinese traditional medicineGUP (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 》 3rd

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