In-vitro drug dissolution models are essential in pharmaceutical research to study drug release from formulations like tablets and capsules.
These models help predict drug dissolution, absorption, and bioavailability, ensuring consistent drug quality.
Principle of a Dissolution Apparatus
Simulates gastrointestinal conditions to study drug release.
Maintains controlled temperature and agitation for dissolution.
Measures drug concentration over time to assess release, absorption, and bioavailability.
Ideal Apparatus Features
Maintains 37°C, ensures consistent agitation, allows easy sampling, supports varied dosage forms, and meets regulatory standards.
Types of Dissolution Apparatus
USP 1 (Basket) – Rotating basket in a dissolution medium.
USP 2 (Paddle) – Uses paddle stirring for uniform mixing.
USP 3 (Reciprocating Cylinder) – Mimics GI motility, ideal for modified-release drugs.
USP 4 (Flow-Through Cell) – Continuous medium flow, good for poorly soluble drugs.
Rotating Disk/Cylinder – Studies surface area impact on dissolution.
GI Simulator – Advanced model replicating stomach, intestines, pH variations, enzymes for realistic absorption predictions.
Factors Affecting Performance
Apparatus Type – Choice depends on drug and dosage form (e.g., USP 1, 2, Flow-Through Cell).
Dissolution Medium – pH, composition, and volume should mimic physiological fluids.
Temperature – Maintained at 37°C for accuracy.
Agitation Rate – Controlled basket/paddle speed or flow rate.
Sampling & Analysis – HPLC, UV spectrophotometry ensure precise drug concentration measurement
