Tips for: Solid Oral Dosage Forms

Drug stability is a critical consideration in the manufacturing of soft gelatin capsules, especially when the capsule shell material itself, gelatin, interacts with the active pharmaceutical ingredients (APIs) within the capsule. These interactions can lead to chemical degradation, reduced bioavailability, or changes in the drug’s physical properties, affecting its therapeutic efficacy. This issue is often more pronounced with moisture-sensitive or pH-sensitive drugs, and overcoming these interactions is essential for ensuring both the stability of the API and the integrity of the capsule.
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In pharmaceutical dosage form manufacturing, one of the challenges faced in the production of soft gelatin capsules is selecting the right solvent for dissolving or suspending the active pharmaceutical ingredient (API). The solvents used in the formulation must be compatible with both the API and the gelatin capsule shell. However, the limited number of suitable solvents can restrict formulation options, especially for drugs that are poorly soluble or require specific solubility characteristics. This issue is compounded when considering regulatory and safety concerns related to solvent toxicity, stability, and extraction during dissolution.
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Moisture sensitivity of active pharmaceutical ingredients (APIs) can lead to significant challenges in capsule dosage form manufacturing, especially in soft gelatin capsules. Moisture absorption can compromise the structural integrity of the gelatin capsule shell, affect the stability of the drug, and alter the release profile of the formulation. This issue becomes particularly prominent when APIs are hygroscopic or susceptible to degradation due to moisture, affecting the overall shelf-life and efficacy of the drug product.
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In the pharmaceutical industry, the incompatibility between active pharmaceutical ingredients (APIs) and gelatin shell materials is a significant challenge in capsule formulation. This issue typically arises in the production of soft gelatin capsules, where the gelatin shell may interact with the active ingredient, affecting the drug’s stability, bioavailability, and overall effectiveness. These incompatibilities can lead to chemical degradation of the drug, changes in the physical properties of the capsule, or alterations in the dissolution profile, which can negatively impact the therapeutic outcomes.
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In pharmaceutical dosage form manufacturing, particularly during capsule filling, uniform drug distribution is a critical issue. This problem is encountered during the formulation of both hard and soft gelatin capsules, where ensuring consistent drug content throughout the fill material is essential for therapeutic efficacy. The issue arises during the blending or mixing of active pharmaceutical ingredients (APIs) with excipients, which can lead to batch-to-batch variability and pose challenges in meeting regulatory standards for content uniformity.
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