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Related Concept Videos

Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism01:21

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...
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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...
In Vitro Drug Dissolution: Compendial Testing Models I01:13

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...
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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...
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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...
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A racemic mixture, or racemate, is an equimolar mixture of enantiomers of a molecule that can be separated using their unique interaction with chiral molecules or media. Racemic mixtures are denoted by the (±)- prefix. This ‘optical rotation descriptor’ applies to the whole solution of a racemic mixture rather than a specific stereoisomer. Enantiomers typically have the same physical and chemical properties. Hence, they are not easily separable. However, enantiomers can exhibit different...

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A discriminating dissolution method for glimepiride polymorphs.

Rudy Bonfilio1, Sumaia A Pires, Leonardo M B Ferreira

  • 1Departamento de Fármacos e Medicamentos, Faculdade de Ciências Farmacêuticas, UNESP-Univ Estadual Paulista, CEP 14801-902, Araraquara, São Paulo, Brazil. rudybonfilio@yahoo.com.br

Journal of Pharmaceutical Sciences
|November 5, 2011
PubMed
Summary
This summary is machine-generated.

Polymorphism significantly impacts glimepiride tablet dissolution. Developing discriminating dissolution methods is crucial for ensuring consistent drug performance and patient safety by controlling raw material crystal forms.

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery
  • Solid-State Chemistry

Background:

  • Glimepiride, an oral antidiabetic, exhibits poor water solubility.
  • It exists in two polymorphic forms (I and II), with Form II showing higher solubility.
  • Drug dissolution rates are influenced by crystal polymorphism, necessitating sensitive analytical methods.

Purpose of the Study:

  • To develop and validate a discriminating dissolution method for 4 mg glimepiride tablets.
  • To assess the impact of glimepiride polymorphism on tablet dissolution properties.

Main Methods:

  • Optimized dissolution conditions: 1000 mL phosphate buffer (pH 6.8) with 0.1% sodium dodecyl sulfate, 50 rpm paddle speed.
  • Validated the developed dissolution method against acceptance criteria.
  • Prepared and tested glimepiride tablets containing Form I and Form II.

Main Results:

  • The developed dissolution method met all validation criteria.
  • Significant differences in dissolution were observed between tablets containing glimepiride Form I and Form II.
  • Polymorphism demonstrably influences glimepiride tablet dissolution behavior.

Conclusions:

  • Strict control of glimepiride raw material polymorphic form is essential.
  • Failure to control polymorphism can lead to unpredictable and undesirable therapeutic outcomes.
  • Validated dissolution testing is critical for quality control of glimepiride formulations.