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Pharmaceutics. Introduction Chapter 1. I. Concepts and tasks. A.concepts (1)pharmaceutics basic theory formulation design drug product preparation techniques quality evaluation - PowerPoint PPT Presentation
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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
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