The Ultimate Resource for Pharmaceutical SOPs and Best Practices
The purpose of this SOP is to establish the procedure for conducting hygroscopicity testing of capsule fill materials. The objective is to evaluate the moisture absorption properties of the materials to ensure stability, prevent clumping, and maintain consistency in capsule fill weights during manufacturing and storage.
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The purpose of this SOP is to define the procedure for granulation development for hard gelatin capsules. Granulation ensures that the active pharmaceutical ingredient (API) and excipients are uniformly distributed in the fill material, improving the flowability, compressibility, and overall quality of the capsule content.
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The purpose of this SOP is to define the procedure for particle size reduction of fill materials used in capsule formulations. The objective is to achieve the desired particle size distribution to ensure uniformity in capsule filling, dissolution, and bioavailability.
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The purpose of this SOP is to establish the procedure for selecting plasticizers for soft gelatin capsule shells, ensuring that the selected plasticizer enhances the flexibility, stability, and overall quality of the capsule shells.
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The purpose of this SOP is to outline the procedure for conducting rheological studies on gelatin to determine its flow properties, which are critical for capsule shell formulation, texture, and performance during manufacturing.
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The purpose of this SOP is to outline the procedure for conducting bioequivalence studies for capsule dosage forms to demonstrate that a generic formulation performs similarly to the reference (innovator) product in terms of bioavailability and therapeutic effectiveness.
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The purpose of this SOP is to establish the procedure for optimizing the fill volume in capsule manufacturing, ensuring accurate and consistent dosage while minimizing material waste and production errors.
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This SOP outlines the procedure for developing prototype capsule dosage forms, ensuring that they meet the desired pharmacological properties, stability, and manufacturability criteria for further scale-up and clinical trials.
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The purpose of this SOP is to establish the procedure for designing clinical trial batches of capsules, ensuring the development of an appropriate and scalable formulation for clinical testing while maintaining regulatory compliance and safety standards.
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The purpose of this SOP is to outline the procedure for conducting solubility studies for soft gelatin capsules to assess the dissolution behavior and bioavailability of the encapsulated active pharmaceutical ingredient (API).
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