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Related Concept Videos

Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism01:21

Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism

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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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Drug Dissolution: Requirements and Profile Comparison01:14

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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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Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

Factors Influencing Drug Absorption: Pharmaceutical Parameters

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Solid dosage forms such as tablets and capsules undergo rigorous manufacturing processes to ensure stability and effectiveness. Their dissolution and absorption properties are influenced significantly by the choice of excipients (inactive ingredients that serve various roles in the formulation), and the methodology applied during production. The manufacturing parameters, such as compression force and granulation techniques, significantly affect dissolution rates. Elevated compression forces...
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Factors Affecting Dissolution: Drug Permeability, Stability and Stereochemistry01:20

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Orally administered drugs primarily enter the systemic circulation via passive diffusion through the intestinal membranes. The drug's absorption is influenced by drug stability in the gastrointestinal GI tract, membrane permeability, the surface area available for absorption, luminal drug concentration, and residence time in the lumen. Drug permeability can be enhanced by adjusting the lipophilicity, polarity, or molecular size of the drug, promoting its passive transport across intestinal...
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Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

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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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In Vitro Drug Dissolution: Compendial Testing Models I01:13

In Vitro Drug Dissolution: Compendial Testing Models I

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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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Related Experiment Video

Updated: Mar 25, 2026

A Package of Established Analytical Tools to Investigate the Solid-State Alteration of Lipid-Based Excipients
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The solid state of rebamipide: preparation, characterization, and dissolution.

Seong Hyeon Jeon1, Young Taek Sohn2

  • 1College of Pharmacy, Duksung Women's University, 419, Ssangmun-Dong, Dobong-Gu, Seoul, 132-714, Korea.

Archives of Pharmacal Research
|February 22, 2016
PubMed
Summary

Two distinct crystal forms of rebamipide, a peptic ulcer agent, were identified. Both forms exhibited similar dissolution profiles and stability under various storage and milling conditions, indicating no significant polymorphic transformation.

Keywords:
Crystal formDTADissolutionPXRDRebamipideTransformation

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Area of Science:

  • Pharmaceutical Sciences
  • Solid-State Chemistry

Background:

  • Rebamipide is a key therapeutic agent for peptic ulcers, marketed as Mucosta(R).
  • Understanding the solid-state properties, including polymorphism, is crucial for drug formulation and efficacy.

Purpose of the Study:

  • To investigate the potential existence of polymorphs and pseudopolymorphs of rebamipide.
  • To characterize the identified crystal forms and assess their stability and dissolution behavior.

Main Methods:

  • Recrystallization was employed to isolate different crystal forms.
  • Characterization utilized differential thermal analysis (DTA), thermogravimetric analysis (TG), powder X-ray diffractometry, infrared spectrometry, and nuclear magnetic resonance (NMR).
  • Dissolution studies and stability testing under various humidity and mechanical stress conditions were performed.

Main Results:

  • Two distinct crystal forms of rebamipide were successfully isolated and characterized.
  • Form 2 exhibited a slightly higher melting point (307.3 °C) compared to Form 1 (305.2 °C).
  • Both forms demonstrated comparable dissolution rates in pH 6.8 buffer and remained stable after prolonged storage and milling.

Conclusions:

  • Rebamipide exists in at least two distinct crystalline forms.
  • These polymorphs exhibit similar physicochemical properties, including dissolution and stability, suggesting no significant impact on therapeutic performance.