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Related Concept Videos

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

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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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Development of Stable and Simple Finasteride 333-μg/mL Suspensions that Minimize Occupational Exposure.

Nathan Ma1, William Perks1, Shirley Law1

  • 1Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.

International Journal of Pharmaceutical Compounding
|November 20, 2020
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Summary
This summary is machine-generated.

A stable finasteride suspension was developed for easier compounding and pharmaceutical acceptability. Formulations retained over 94% finasteride concentration for 90 days, with minimal occupational exposure risk.

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Formulation
  • Stability Testing

Background:

  • Finasteride is not available in a liquid form, necessitating the development of alternative formulations.
  • Compounding liquid finasteride is crucial for patients requiring precise dosing or those with difficulty swallowing tablets.

Purpose of the Study:

  • To develop and assess a stable finasteride suspension formulation.
  • To evaluate the pharmaceutical acceptability, stability, and potential for occupational exposure of the finasteride suspension.

Main Methods:

  • Commercial finasteride tablets and pure powder were used to prepare suspensions in water, Oral Mix, and Oral Mix SF.
  • Stability was assessed in amber polyethylene terephthalate bottles and polypropylene oral syringes at 25°C and 4°C for 90 days.
  • Finasteride concentration was quantified using a validated stability-indicating liquid chromatographic method; occupational exposure was simulated.

Main Results:

  • All finasteride suspension formulations retained over 94.3% of the initial concentration after 90 days of storage.
  • Stability was consistent across different vehicles (water, Oral Mix, Oral Mix SF), containers, and storage temperatures (25°C, 4°C).
  • Simulated occupational exposure tests did not detect finasteride in airborne samples, suggesting low exposure risk.

Conclusions:

  • Stable finasteride suspension/dispersion formulations (333 µg/mL) can be prepared with high drug recovery (>94.3%) after 90 days.
  • The developed finasteride suspensions demonstrate good stability and pharmaceutical acceptability.
  • While airborne finasteride was not detected, adherence to safety protocols is recommended due to regulatory considerations.