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Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism01:21

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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).
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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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Recrystallization is a purification technique used to separate impurities from solid compounds. In this technique, no chemical reactions occur. Instead, it exploits physical properties only, specifically, the solubility differences between the desired compound and impurities, either at a single temperature or at different temperatures, and under other selected conditions. The solid-solution equilibrium (solubility equilibrium) of each component in the solution represents a binary phase...
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Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

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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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Colloidal precipitates

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The high insolubility of some precipitates can result in an unfavorable relative supersaturation. This can lead to colloidal particles with a large surface-to-mass ratio, where adsorption is promoted. For instance, in the precipitation of silver chloride, silver ions are adsorbed on the surface of the colloidal particles, forming a primary layer. This layer attracts ions of opposite charge (such as nitrate ions), forming a diffuse secondary layer of adsorbed ions. This electric double layer...
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Factors Affecting Dissolution: Particle Size and Effective Surface Area01:23

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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...
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Mitigating Drug Stability Challenges Through Cocrystallization.

Jamshed Haneef1, Mohd Amir2, Nadeem Ahmed Sheikh2

  • 1Department of Pharmaceutical Chemistry, School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi, 110 062, India. jamshedhaneef@jamiahamdard.ac.in.

AAPS Pharmscitech
|February 9, 2023
PubMed
Summary

Pharmaceutical cocrystals offer a novel approach to enhance drug stability, addressing challenges in drug development. This method improves drug properties without chemical modification, potentially reducing costs and launch times.

Keywords:
cocrystalcrystal engineeringdegradation pathwaydrug stabilitystructure–property relationship

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Area of Science:

  • Pharmaceutical Science
  • Materials Science
  • Drug Discovery

Background:

  • Drug stability is critical throughout a pharmaceutical product's lifecycle, impacting development timelines and costs.
  • Traditional formulation approaches to enhance drug stability can be time-consuming and require extensive optimization.
  • Pharmaceutical cocrystals provide a non-covalent strategy to modify drug properties, including stability.

Purpose of the Study:

  • To highlight the efficacy of pharmaceutical cocrystallization in overcoming stability challenges with difficult drug molecules.
  • To provide insights into the structural aspects and mechanisms underlying cocrystal-mediated stability enhancement.
  • To propose a strategic framework for utilizing cocrystallization to improve drug molecule stability.

Main Methods:

  • Review of existing literature and case studies on pharmaceutical cocrystals for drug stability.
  • Analysis of structural data of cocrystals to elucidate stability-enhancing mechanisms.
  • Development of a guided strategy for applying cocrystallization to modulate drug stability.

Main Results:

  • Cocrystallization effectively mitigates stability issues in various challenging drug molecules.
  • Structural insights reveal specific interactions that contribute to improved parent drug stability within cocrystals.
  • Case studies demonstrate successful application of cocrystals to enhance drug stability.

Conclusions:

  • Pharmaceutical cocrystals represent a viable and efficient strategy for improving the stability of drug molecules.
  • Understanding cocrystal structures and formation mechanisms is key to successful application.
  • Cocrystallization offers a promising avenue for addressing stability concerns in drug development and fixed-dose combinations.