<< Back to Product List
Biopharmaceutics v2.0
Source PCCAL, University of Michigan
ISBN: 0 9532751 7 5
Versions Available Internet
Subject Specialist Gordon Armidon
Summary

Screen shot from the package		 This package is designed to introduce the student to biopharmaceutics. The student first studies the basics of biopharmaceutics then continues by looking at the application of biopharmaceutics to oral drug delivery. The student finishes by looking at the regulatory standards for oral drug delivery.
Contents

Basics of Pharmaceutics
Oral Drug Delivery
  • Gastrintestinal Tract Factors
  • Immediate Release Dosage forms
  • Controlled Release Dosage Forms
Regulatory standards for Drug delivery
  • Biopharmaceutical Drug Classification
  • Bioequivalent Criteria
  • Regulation on Dissolution and Permeability
Summary of Selected Sections
Basics of Biopharmaceutics

i) Biopharmaceutics and Pharmacokinetics (Biopharmaceutics - definition and relating terms; Bioavailability - definition, Cpvs t: AUC, Tmax, Cmax; Pharmacokinetics - definition, absorption, disposition, elimination, kinetic analysis - models, parameters - t1/2, K, (abs)t1/2, ka, Vd; Bioequivalence - definition, therapeutic equivalence evaluation codes).
ii) Transport (Paracellular Transport; Passive Transport - Fick’s First Law; Endocytosis Transport; Carrier Mediated Transport - active transport (primary and secondary, carrier-mediated transport); A Theory of Mass Transport).
iii) Different Routes of Drug Administration (Routes of Administration - buccal or sublingual, eye, IA, IM, inhalation, IP, IV, nasal, rectal, SC, spinal, topical and vaginal).

Oral Drug Delivery

Gastrointestinal Tract Factors

i) Anatomy and Morphology (Overview; Stomach; Small Intestine; Large Intestine).
ii) Secretion (Salivary Secretion; Gastric Secretion; Pancreatic Secretion; Biliary Secretion; Intestinal Secretion).
iii) Motility (Overview; Stomach - gastric emptying, fed vs fasted state; Small Intestine - transit time, fed vs fasted state; Large Intestine - transit time, fed vs fasted state).
v) Nutrient Absorption Effect (Fat; Carbohydrate; Protein).

Controlled Released Dosage Forms

i) Introduction.
ii) Terminology (Sustained Release; Controlled Release; Zero-Order Release; First-Order Release).
iii) Factors Influencing CR (Biological Factors - elimination rate, half-life, absorption, metabolism, duration of action; Physicochemical Factors - dose size, ionization, pKa, aqueous solubility, partition coef ficient, stability).
iv) Types of Oral CR (Diffusional Systems - reservoir devices, matrix devices; Dissolution Controlled Systems; Diffusion and Dissolution Controlled Systems; Osmotically Controlled Systems; Ion-Exchange Systems).
v) Simulation (Defining Models; Nifedipine; Zero-Order Release Simulations; First-Order Release Simulations).
vi) Regulation (Potential Bioavailability Problems - food administration, First Pass Metabolism, Dose Dumping; Demonstration of Safety and Efficacy; Dissolution Test).