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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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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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Rational drug product design integrates knowledge of the drug’s physicochemical properties, formulation components, manufacturing techniques, and intended route of administration. Each factor influences the drug’s performance, including how it is released, absorbed, and eliminated in the body.The physicochemical properties of a drug—such as solubility, stability, and particle size—affect its compatibility with excipients and the choice of dosage form. Excipients, though...
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Modular solid dosage form design - Application to pH-independent release of a weak-base API.

Mario A Cano-Vega1, Meng Deng2, Rodolfo Pinal3

  • 1Department of Agricultural and Biological Engineering, Purdue University, West Lafayette, IN, USA; Bindley Bioscience Center, Purdue University, West Lafayette, IN, USA.

International Journal of Pharmaceutics
|March 29, 2021
PubMed
Summary

This study introduces a novel modular approach for designing solid dosage forms, creating pH-independent drug release for weak-base active pharmaceutical ingredients (APIs) using prefabricated components.

Keywords:
3D assemblyDissolutionExcipient functionalityModular dosage formsPolymer filmsWeak bases

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Area of Science:

  • Pharmaceutical Technology
  • Drug Delivery Systems
  • Materials Science

Background:

  • Traditional solid dosage form design relies on blending and compaction.
  • Weak-base active pharmaceutical ingredients (APIs) often exhibit pH-dependent drug release, complicating formulation.
  • Achieving consistent drug release across different physiological pH environments is a significant challenge.

Purpose of the Study:

  • To investigate a novel modular approach for solid dosage form design.
  • To develop pH-independent drug release profiles for a weak-base API using prefabricated components.
  • To assess the drug release kinetics and mechanisms of these modular dosage forms.

Main Methods:

  • Formulated tablet-like dosage forms using hydroxypropyl methylcellulose film wafers loaded with ciprofloxacin (CPR) and citric acid (CA).
  • Assembled modular dosage forms by stacking CPR-wafers and CA-wafers in alternating sequences.
  • Evaluated in vitro drug release profiles at pH 1.2 and pH 6.8, comparing modular assemblies with CPR-wafers only.
  • Utilized f1 and f2 factors to assess the similarity of drug release profiles and employed kinetic modeling.

Main Results:

  • Modular dosage forms with citric acid (CA) wafers demonstrated overlapping drug release profiles at pH 1.2 and pH 6.8.
  • In the absence of CA-wafers, ciprofloxacin (CPR) release was significantly slower at pH 6.8 compared to pH 1.2.
  • Kinetic modeling indicated polymer erosion as the primary drug release mechanism for the pH-independent profiles.
  • The modular assemblies behaved as single units, with initial geometry (surface area, volume, SA/V ratio) influencing release kinetics.

Conclusions:

  • A novel modular assembly approach enables pH-independent drug release for weak-base APIs.
  • This method offers a viable alternative to traditional blending and compaction for solid dosage forms.
  • The design allows for predictable drug release kinetics, influenced by the dosage form's initial geometry.