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Approaches to Design Controlled Release Formulations

  • Novel Drug Delivery Systems (NDDS) aim to improve drug therapeutic efficacy and safety by ensuring the timely delivery of the drug in required amounts to the target site.

  • Controlled release formulations, a type of NDDS, release the drug at a predetermined rate to maintain therapeutic drug concentrations over prolonged periods.

Principles of Controlled Release Formulations

Approaches to Design Controlled Release Formulations

A. Based on Diffusion

  • Diffusion-controlled systems rely on the movement of drug molecules from a region of higher concentration to one of lower concentration through a barrier or matrix.

Reservoir Systems:

  • Structure: Drug core surrounded by a polymeric membrane.

  • Mechanism: Drug diffuses through the membrane at a controlled rate.

  • Characteristics: Provides zero-order release kinetics; rate is independent of drug concentration.

Matrix Systems:

  • Structure: Drug dispersed uniformly within a polymer matrix.

  • Mechanism: Drug release occurs as it diffuses out of the matrix.

  • Characteristics: Release rate decreases over time; suitable for both hydrophilic and hydrophobic drugs.

B. Based on Dissolution

  • Dissolution-controlled systems regulate drug release through the dissolution of the drug or its coating.

Encapsulation Dissolution Systems:

  • Structure: Drug particles or granules coated with a slow-dissolving material.

  • Mechanism: Coating dissolves gradually, releasing the drug.

  • Characteristics: Can provide controlled release by varying coating thickness.

Matrix Dissolution Systems:

  • Structure: Drug embedded in a matrix of a dissolvable carrier.

  • Mechanism: Matrix dissolves slowly, liberating the drug.

  • Characteristics: Suitable for drugs with poor water solubility.

C. Based on Ion Exchange Principles

  • Ion-exchange systems utilize resins that bind ionic drugs, releasing them in exchange for ions in the gastrointestinal fluids.

Ion-Exchange Resins:

  • Structure: Insoluble polymers containing ionizable groups.

  • Mechanism: Drug-resin complexes exchange ions with GI fluids, releasing the drug.

  • Characteristics: Release rate depends on the ion concentration and pH of the environment.

Applications:

  • Taste Masking: Can mask unpleasant tastes of drugs.

  • Sustained Release: Provides prolonged drug action through controlled ion exchange.


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