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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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Sublimation is the direct transformation of a solid to a gaseous state. For instance, at standard pressure and room temperature, solid carbon dioxide sublimes to gaseous carbon dioxide. The phase diagram depicts the conditions required for sublimation. This process occurs at the solid-gas phase boundary and is not observed above the triple point of the substance. The reverse of sublimation is called deposition, where a gaseous substance condenses directly into a solid. Sublimation and...
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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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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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Mini Review on the Lyophilization: A Basic Requirement for Formulation Development and Stability Modifier.

Sachin Joshi1, Priya Jindal1, Shreastha Gautam1

  • 1Department of Pharmaceutical Quality Assurance, ISF College of Pharmacy, Moga, India.

Assay and Drug Development Technologies
|February 26, 2025
PubMed
Summary
This summary is machine-generated.

Freeze-drying, or lyophilization, is a vital process for creating stable pharmaceutical formulations. This technique enhances drug stability, efficacy, and delivery across various dosage forms.

Keywords:
drug deliveryfreeze-dryinglyophilizationstabilitysublimation

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Area of Science:

  • Pharmaceutical Sciences
  • Chemical Engineering
  • Materials Science

Background:

  • Freeze-drying (lyophilization) is a widely adopted technique for pharmaceutical formulation, particularly for complex active components and drug delivery systems.
  • It involves water removal via sublimation, crucial for moisture-sensitive, thermolabile, or air-degradable therapeutic compounds.
  • Excipients like stabilizers, buffers, and bulking agents are often essential for maintaining product appearance and long-term stability.

Purpose of the Study:

  • To provide a comprehensive overview of the lyophilization process.
  • To discuss the principles, excipients, and emerging technologies in lyophilized medicine compositions.
  • To highlight the applications of lyophilization in various scientific and pharmaceutical fields.

Main Methods:

  • The article reviews the fundamental principles of lyophilization, including freezing, primary drying (sublimation), and secondary drying (desorption).
  • It examines the role of specific excipients in formulating lyophilized products.
  • The discussion includes an overview of novel lyophilization technologies and their applications.

Main Results:

  • Lyophilization is effective for diverse dosage forms (oral, inhalation, parenteral), improving therapeutic efficacy and delivery.
  • The process is critical for enhancing the solubility and bioavailability of poorly soluble drugs.
  • It is instrumental in preserving biological samples and stabilizing reference standards in pharmacological research.

Conclusions:

  • Lyophilization is essential for ensuring the stability, efficacy, and safety of pharmaceutical products throughout development and lifecycle management.
  • This technique offers significant advantages for drug delivery systems and the formulation of sensitive compounds.
  • Advancements in lyophilization technology continue to expand its utility in pharmaceutical research and product development.