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In Vitro Drug Dissolution: Compendial Testing Models I

In Vitro Drug Dissolution: Compendial Testing Models I

Compendial dissolution methods are standardized procedures defined by pharmacopeias to evaluate the rate at which a drug dissolves in a specific medium. These methods ensure batch-to-batch consistency, enable quality control, and support the prediction of drug bioavailability. They are critical for both immediate and modified-release drug products.The apparatuses used for dissolution testing differ in their design and mechanical function, but all aim to simulate the physiological environment of...

Modified-Release Drug Delivery Systems: Rate-Programmed I

Modified-Release Drug Delivery Systems: Rate-Programmed I

Rate-programmed drug delivery systems (DDS) are designed to release drugs at specific, controlled rates to maintain consistent therapeutic levels. These systems are categorized based on their release mechanisms, including dissolution-controlled DDS, diffusion-controlled DDS, and combined dissolution-diffusion-controlled DDS.In dissolution-controlled DDS, the release rate depends on the slow dissolution of the drug itself or the surrounding matrix. Drugs with inherently slow dissolution rates,...

In Vitro Drug Dissolution: Compendial Testing Models II

In Vitro Drug Dissolution: Compendial Testing Models II

Various dissolution methods are utilized to assess a drug’s dissolution rate, including the flow-through cell, paddle-over-disk, cylinder, and reciprocating disk methods.The flow-through cell apparatus (USP (United States Pharmacopeia) method 4) comprises a reservoir for the dissolution medium and a pump that propels the medium through the cell containing the test sample. This method is crucial for assessing modified-release dosage forms with minimally soluble active ingredients, maintaining...

Stratified Sampling Method

Stratified Sampling Method

Sampling is a technique to select a portion (or subset) of the larger population and study that portion (the sample) to gain information about the population. The sampling method ensures that samples are drawn without bias and accurately represent the population. Because measuring the entire population in a study is not practical, researchers use samples to represent the population of interest.
To choose a stratified sample, divide the population into groups called strata and then take a...

Sampling Plans

Sampling Plans

Sampling is a crucial step in analytical chemistry, allowing researchers to collect representative data from a large population. Common sampling methods include random, judgmental, systematic, stratified, and cluster sampling.
Random sampling is a method where each member of the population has an equal chance of being selected for the sample. It involves selecting individuals randomly, often using random number generators or lottery-type methods. For example, when analyzing the properties of a...

In Vitro Drug Dissolution: Alternative Methods

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Alternative drug dissolution methods include the rotating bottle, intrinsic dissolution test, peristalsis, and the Franz diffusion cell method. The rotating bottle method involves meticulously rotating tightly capped controlled-release beads in a temperature-controlled bath. Periodic decanting of samples allows for residue assay, followed by refilling with fresh medium and testing at various pH levels to emulate the gastrointestinal tract conditions.In contrast, the intrinsic dissolution test...

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An Analog Macroscopic Technique for Studying Molecular Hydrodynamic Processes in Dense Gases and Liquids

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Discrete element method (DEM) simulations of stratified sampling during solid dosage form manufacturing.

Bruno C Hancock¹, William R Ketterhagen

¹Pfizer Inc., Eastern Point Road, Groton, CT 06340, United States.

International Journal of Pharmaceutics

|June 4, 2011

Summary

Uniform powder sampling during manufacturing is key for accurate dosage form content uniformity. Discrete element model simulations show uniform sampling best identifies segregation, unlike sigmoidal or truncated methods.

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Area of Science:

Pharmaceutical Manufacturing
Powder Technology
Computational Modeling

Background:

Content uniformity is critical for solid dosage form efficacy and safety.
Powder segregation during hopper discharge can impact blend uniformity.
Current sampling guidelines may not fully capture segregation dynamics.

Purpose of the Study:

To evaluate the impact of different sampling strategies on estimating dosage form content uniformity.
To compare simulation-based sampling approaches with current industry best practices.
To understand the influence of sample size, number, and location on segregation detection.

Main Methods:

Utilized discrete element model (DEM) simulations for powder discharge from hoppers.
Analyzed various sampling scenarios, including uniform, sigmoidal, and truncated approaches.
Assessed the effects of sample size, number of locations, and samples per location.

Main Results:

Uniform sampling across the discharge process most accurately identified segregation trends.
Sigmoidal sampling overestimated segregation, while truncated sampling underestimated it.
Sample size significantly affected absolute potency relative standard deviation (RSD); location and number of samples had minor effects.

Conclusions:

DEM simulations provide valuable insights into powder flow and sampling effectiveness.
Uniform sampling protocols are recommended for accurate assessment of content uniformity.
Findings guide the selection of optimal sampling strategies in pharmaceutical manufacturing.