The International Generic Drug Regulators Programme (IGDRP) brings together regulatory authorities from different countries and regions to harmonize and standardize practices for generic drug evaluation. Dissolution testing is a critical part of this process, ensuring the quality and bioequivalence of generic formulations across global markets. Below are the key dissolution requirements typically considered by IGDRP…
Development of an appropriate dissolution method for quality control purposes requires consideration of many factors and a balance of different needs. The method is typically distinctive to each drug product because of the unique characteristics of the active ingredient, the formulation, and the manufacturing process. Dissolution testing of solid oral dosage forms has been used…
Yesterday, I started working through the Noyes-Whitney equation with the intrinsic dissolution rate (k2). Today, let’s discuss the impact of surface area on dissolution. The equation shows us that as the surface area of a formulation increases, so does the dissolution rate. Using this, a formulator can greatly increase or decrease the dissolution rate of…
In the pharmaceutical industry, the Q value is a key parameter in dissolution testing that ensures the quality and performance of solid oral dosage forms like tablets and capsules. But what exactly does it mean? The Q value represents the minimum percentage of the active pharmaceutical ingredient (API) that must dissolve in a specified time…
Once the dosage form reaches the absorption site, it must disintegrate, deaggregate and release its therapeutic agent. The lack of ability of a drug to go into solution is sometimes a more important limitation to its overall rate of absorption than its ability to permeate the intestinal mucosa. For many drugs that cross the intestinal…
USP <711> contains a couple references to pooled sampling for dissolution. What is pooled sampling and when is it appropriate? What risks are there with pooled sampling? Pooled sampling is a procedure where each sample from a dissolution time point is combined into a single sample. Pooled sampling is only done for immediate-release dosage…
One major criterion for selecting the QC dissolution method should be its discriminatory power to show changes in the critical attributes of the release mechanism of the chosen formulation. The discriminatory power is the ability of a test procedure to discriminate between batches manufactured with different critical process parameters and /or critical material attributes…
When you’re discussing dissolution, it is usually about solid oral dosage forms. Dissolution units can actually be used for any product which releases a drug over time such as medical devices, injectables, and semisolids. The USP has a chapter dedicated to testing semisolids which is USP General Chapter <1724> Semisolid Drug Products – Performance Tests. …
