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Published byLindsey Murphy Modified over 9 years ago
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1 Abu Alam Ph.D. Advisory Committee for Pharmaceutical Science and Clinical Pharmacology July 23, 2008
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2 Locally Acting Oral Drugs For the Treatment of Gastrointestinal Conditions
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3 Drug Substance Purity Impurity Molecular Size Solubility (pH 1 to 8) Permeability Degradation Analytical Method Specification Stability
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4 Dosage Form Formulation Excipients Manufacturing process Dosage form design Tablet Capsule Specifications Stability
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5 Schematic of GI Transit Oral Dosage Stomach pH 1.2 Duodenum pH 4.5 Elimination Feces Colon pH 7.5 Jejunum pH 6.8
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6 Dissolution Illustrations USP Method I or II pH 1.2 (Sodium Chloride)
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7 Dissolution Illustrations USP Method I or II pH 4.5 (Acetate Buffer)
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8 Dissolution Illustrations USP Method I or II pH 6.8 (Phosphate Buffer)
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9 Schematic of Disposition Oral Dosage Dissolution GI Tract Local Action GI Tract Elimination Feces Systemic Absorption Elimination Systemic Toxicity
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10 Criteria Not specifically absorbed Local action Dissolution is pH independent Freely available at site of action No permeation Vancomycin capsule fits the criteria
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11 Conclusion Comparative, superimposable dissolution profile Rate and extent of dissolution are same In Vivo bioequivalency is unnecessary Clinical trial to prove safety and efficacy are unnecessary
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