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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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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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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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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...
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An Overview on Recent Patents and Technologies on Solid Dispersion.

Ritu Kaushik1, Vikas Budhwar1, Deepak Kaushik1

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Enhancing oral bioavailability of poorly water-soluble drugs is challenging. Solid dispersions offer a promising formulation approach, with various preparation methods and patented technologies reviewed.

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery Systems

Background:

  • Poor water solubility significantly limits oral drug bioavailability.
  • Traditional methods like salt formation and particle size reduction have inherent limitations.

Purpose of the Study:

  • To review preparation techniques for solid dispersions (SDs) for poorly water-soluble drugs.
  • To analyze patent landscape and commercial technologies related to SDs.

Main Methods:

  • Review of scientific literature and patent databases.
  • Analysis of various solid dispersion preparation methods (solvent melting, hot-melt extrusion, solvent evaporation, cryogenic processing).
  • Discussion of carrier selection and physicochemical characterization.

Main Results:

  • Solid dispersion is a highly effective strategy for enhancing drug solubility and dissolution.
  • Numerous patents demonstrate the growing interest and innovation in SD preparation techniques.
  • Commercial platforms like Solumera, Hovione, and Kinetisol leverage SD technology.

Conclusions:

  • Solid dispersion technology is crucial for developing oral formulations of poorly soluble drugs.
  • Understanding preparation methods, carrier properties, and molecular arrangements is key to successful SD formulation.
  • Patented technologies offer advanced solutions for drug solubility enhancement.