Dissolution Testers
Dissolution testers are essential analytical instruments used to evaluate the rate and extent of drug release from dosage forms under controlled conditions. Pharmaco Global offers dissolution testers for pharmaceutical testing engineered for precise control of temperature, agitation, and testing parameters, ensuring high repeatability and compliance with global pharmacopeial standards.
These systems are widely used in pharmaceutical quality control, formulation development, and regulatory testing to assess drug release profiles and ensure batch consistency. Their reliable performance and automated capabilities support accurate analysis, efficient laboratory workflows, and GMP-compliant operations in regulated environments.
Frequently Asked Questions
A dissolution tester measures rate and extent of drug release from solid oral dosage forms into liquid media under standardised conditions. Used in pharmaceutical QC for batch consistency, formulation development, IVIVC studies, and regulatory submissions — mandated by USP , European Pharmacopoeia 2.9.3, and Japanese Pharmacopoeia.
Apparatus 1 (basket) uses a rotating wire mesh basket — preferred for floating tablets and capsules. Apparatus 2 (paddle) rotates above the dosage form — the most widely used due to its versatility. Standard speeds: 100 RPM for Apparatus 1; 50–75 RPM for Apparatus 2.
USP defines four apparatus: Apparatus 1 (rotating basket) for capsules and floating dosage forms; Apparatus 2 (paddle) for most tablets; Apparatus 3 (reciprocating cylinder) for extended-release beads; Apparatus 4 (flow-through cell) for poorly soluble drugs, implants, and transdermal patches requiring continuously fresh dissolution media.
The tester maintains aqueous media at 37°C with controlled agitation simulating GI motility. pH buffers replicate GI segments: 0.1N HCl (gastric, pH 1.2), acetate (pH 4.5), phosphate (pH 6.8). Biorelevant media FaSSIF and FeSSIF incorporate bile salts to better predict in vivo drug absorption.
PVT is a USP-mandated test using certified prednisone reference standard tablets to verify the apparatus produces accurate, reproducible results independent of manufacturer or laboratory. Required at installation, after relocation, and periodically. A failing PVT requires investigation before the instrument can be used for any pharmaceutical batch testing.
Common dissolution media: 0.1N HCl (pH 1.2, gastric), acetate buffer (pH 4.5), phosphate buffer (pH 6.8 and 7.4), simulated gastric fluid (SGF), simulated intestinal fluid (SIF), and biorelevant media FaSSIF and FeSSIF — containing bile salts and lecithin to better predict in vivo drug absorption profiles.
IQ confirms installation per manufacturer specs. OQ tests RPM accuracy, temperature uniformity (37.0 ± 0.5°C), wobble (≤1.0 mm), shaft verticality, and vessel dimensions. PQ uses USP Performance Verification Testing (PVT) with prednisone reference tablets. All stages require signed protocols and reports retained in the instrument qualification file.
Disintegration (USP ) measures time for a tablet to physically break apart — a pass/fail structural test. Dissolution measures rate and extent the drug actually dissolves into solution — the clinically meaningful measure that predicts bioavailability. A tablet can disintegrate rapidly but still dissolve poorly if the drug is poorly soluble.
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