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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...
Crystal Growth: Principles of Crystallization01:25

Crystal Growth: Principles of Crystallization

Crystallization is a phase transformation process in which crystals are precipitated from a supersaturated solution or formed from other sources. During crystallization, atoms or molecules arrange themselves into a well-defined, rigid crystal lattice to minimize energy.
Initiating crystallization involves manipulating the concentration of the solute and the temperature of the solution. Since crystal growth occurs when the ratio of concentration and solubility of the solute in the solvent – the...
Recrystallization: Solid–Solution Equilibria01:10

Recrystallization: Solid–Solution Equilibria

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...
Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

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,...
Polymer Classification: Crystallinity01:21

Polymer Classification: Crystallinity

Unlike ionic or small covalent molecules, polymers do not form crystalline solids due to the diffusion limitations of their long-chain structures. However, polymers contain microscopic crystalline domains separated by amorphous domains.
Crystalline domains are the regions where polymer chains are aligned in an orderly manner and held together in proximity by intermolecular forces. For example, chains in the crystalline domains of polyethylene and nylon are bound together by van der Waals...
Precipitation Processes01:12

Precipitation Processes

The experimental conditions in a gravimetric analysis should be optimized to maximize the particle size and purity of the obtained precipitate. Ideally, the concentration of the precipitating reagent should be low with effective stirring to maintain low relative supersaturation for the growth of large crystals. In homogeneous precipitation, the precipitant is slowly generated by a chemical reaction in the solution to avoid local reagent excesses. For example, urea decomposes gradually to...

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Optimization of Crystal Growth for Neutron Macromolecular Crystallography
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Published on: March 13, 2021

Crystal polymorphism in chemical process development.

Alfred Y Lee1, Deniz Erdemir, Allan S Myerson

  • 1Merck & Co. Inc., Rahway, NJ 07065, USA. alfred.lee@merck.com

Annual Review of Chemical and Biomolecular Engineering
|March 22, 2012
PubMed
Summary
This summary is machine-generated.

Polymorphism, the existence of multiple crystal forms, is crucial in pharmaceuticals. Understanding and controlling solid-state forms ensures drug quality and manufacturing consistency.

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Area of Science:

  • Pharmaceutical Science
  • Materials Science
  • Chemical Engineering

Background:

  • Polymorphism is common in molecular crystals, significantly impacting the pharmaceutical industry.
  • The solid-state form of a drug is a critical quality attribute, influencing manufacturing and storage.
  • Inconsistent solid phases can lead to severe consequences in drug substances and products.

Purpose of the Study:

  • To review the prevalence and importance of polymorphism in pharmaceutical development.
  • To describe methods for solid-form screening and selection.
  • To provide case studies on controlling polymorphs in chemical development.

Main Methods:

  • Literature review on polymorphism in molecular crystals.
  • Discussion of solid-state screening and selection strategies.
  • Analysis of case studies in polymorph control from a chemical development standpoint.

Main Results:

  • Polymorphism is pervasive and highly relevant to pharmaceutical quality.
  • Systematic screening and judicious selection of solid forms are essential for drug development.
  • Effective strategies exist for controlling polymorphs during chemical development.

Conclusions:

  • Understanding and controlling drug polymorphism is vital for ensuring product quality and safety.
  • Appropriate solid-form selection mitigates risks associated with manufacturing and storage inconsistencies.
  • Chemical development approaches can successfully manage polymorphic outcomes.