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Factors Influencing Drug Absorption: Drug Dissolution

Factors Influencing Drug Absorption: Drug Dissolution

The pharmacokinetic journey of drugs from solid oral dosage forms into systemic circulation is multifaceted. It begins with disintegration, a prerequisite ensuring a solid dosage form's subdivision into minute particles. Dissolution occurs next as these granulated entities solubilize in gastrointestinal fluids. This solubilization is crucial for the succeeding stage, permeation, which describes the traversal of the drug across the intestinal membrane and its subsequent entry into the blood...

Factors Affecting Dissolution: Particle Size and Effective Surface Area

Factors Affecting Dissolution: Particle Size and Effective Surface Area

Dissolution kinetics, an essential aspect of oral drug delivery, is significantly influenced by the drug's particle size. According to the Noyes-Whitney dissolution model, the dissolution rate correlates directly with the drug's surface area. The larger the surface area, the higher the drug's solubility in water, leading to a faster drug dissolution rate. Reducing particle size increases the effective surface area, enhancing the dissolution process. Micronization and nanosizing are employed to...

Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism

Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism

Polymorphism refers to the existence of a drug substance in multiple crystalline forms, known as polymorphs. Recently, this term has been expanded to include solvates (forms containing a solvent), amorphous forms (non-crystalline forms), and desolvated solvates (forms from which the solvent has been removed).
Some polymorphic crystals possess lower aqueous solubility than their amorphous counterparts, leading to incomplete absorption. For instance, the oral suspension of Chloramphenicol, which...

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...

Drug Dissolution: Requirements and Profile Comparison

The acceptance criteria for dissolution profile data are anchored in Q values, representing the percentage of drug dissolved within a specified period. This assessment unfolds in three stages:First Stage: The test passes if all six drug dosage units are equal to or greater than Q plus 5%; otherwise, the sample proceeds to the second stage.Second Stage: The average of twelve units must be equal to or greater than Q, with no unit falling below Q - 15% to pass; if not, it progresses to the final...

Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence

Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence

Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...

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Related Experiment Video

Updated: Jul 24, 2026

Coherent anti-Stokes Raman Scattering (CARS) Microscopy Visualizes Pharmaceutical Tablets During Dissolution

Coherent anti-Stokes Raman Scattering (CARS) Microscopy Visualizes Pharmaceutical Tablets During Dissolution

Published on: July 4, 2014

Dissolution evaluation of marketed tetracyclines solid oral dosage forms.

C H Yamamoto¹, T de J Pinto, M S Alves

¹Faculdade de Ciências Farmacêuticas da Universidade de São Paulo, Brasil.

Bollettino Chimico Farmaceutico

|August 2, 2000

Summary

Most pharmaceutical tetracycline products meet quality standards, with only a small percentage failing dissolution tests. This highlights the importance of stringent quality control in pharmaceutical manufacturing for antibiotics like tetracycline.

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Area of Science:

Pharmaceutical Sciences
Drug Quality Control
Pharmacology

Background:

Tetracyclines are widely manufactured antibiotics, commonly formulated as capsules.
Ensuring the quality and efficacy of these widely used drugs is crucial for patient safety.
Pharmaceutical industries must adhere to strict manufacturing standards for antibiotic production.

Purpose of the Study:

To assess the in vitro quality performance of commercially available tetracycline and oxytetracycline hydrochloride capsules.
To evaluate the quality of doxycycline hydrochloride enteric-coated tablets.
To determine compliance with established pharmacopeial standards for these antibiotic formulations.

Main Methods:

Analyzed 36 samples from 12 different pharmaceutical producers.
Tested tetracycline and oxytetracycline hydrochloride capsules (500 mg) and doxycycline hydrochloride enteric-coated tablets (100 mg).
Utilized in vitro dissolution testing following United States Pharmacopeia (USP) XXIII procedures.

Main Results:

Out of 36 analyzed samples, 34 (94.4%) met the quality specifications.
Two samples (5.6%) failed to meet the dissolution requirements and were rejected.
A single producer was associated with the rejected samples, indicating a potential quality issue.

Conclusions:

The majority of commercially available tetracycline and doxycycline formulations demonstrate acceptable in vitro quality.
A small proportion of products failed dissolution testing, necessitating attention to manufacturing consistency.
The findings underscore the critical need for robust quality assurance systems in pharmaceutical production of antibiotics.