Tips for: Solid Oral Dosage Forms

Encapsulating oils in soft gelatin capsules is a common practice for delivering lipophilic active pharmaceutical ingredients (APIs) in a convenient oral dosage form. However, oils with high peroxide content present a unique challenge. Peroxides, which form during the oxidation of oils, are unstable and can cause degradation of both the API and the capsule itself. The presence of peroxides in oils can lead to reduced efficacy of the drug, potential side effects, and compromised product stability. Therefore, managing peroxide content in oils used for encapsulation is crucial for ensuring the safety and effectiveness of soft gelatin capsules.
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Achieving the required viscosity for soft gelatin fill material is a critical step in the development of soft gelatin capsules. The viscosity of the fill material impacts the encapsulation process, including the ease with which the material can be filled into the capsule, as well as the stability, flowability, and uniformity of the final product. Inadequate viscosity can lead to problems such as poor capsule sealing, uneven fill, or inconsistent dosing, all of which can affect the quality of the product. On the other hand, excessive viscosity can cause difficulties in handling and processing, and may lead to clogging or operational issues during capsule filling.
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High-shear granulation is commonly used in the pharmaceutical industry for the preparation of granules that are later compressed into tablets or filled into capsules. However, this process can be incompatible with certain capsule formulations, particularly when dealing with APIs that are sensitive to shear forces or those requiring specific formulation conditions. The shear forces applied during granulation can alter the particle size, morphology, and solubility of the drug or its excipients, leading to challenges in ensuring uniformity, stability, and bioavailability in capsule formulations.
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Developing stable dispersions for soft gelatin capsules can be challenging, particularly when dealing with poorly soluble active pharmaceutical ingredients (APIs) or those that are sensitive to environmental factors such as temperature, pH, or light. Dispersions, which involve the uniform distribution of the API within a liquid or semi-solid medium, are critical for ensuring the efficacy and bioavailability of the drug. However, formulating these dispersions into soft gelatin capsules requires overcoming issues like phase separation, viscosity instability, and poor API solubility, all of which can impact the performance of the final product.
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The unpleasant odor of certain active pharmaceutical ingredients (APIs) can be a major challenge in drug formulation, especially when developing oral dosage forms such as capsules and tablets. APIs with strong or bitter smells, such as those used in antibiotics, vitamins, or certain hormonal treatments, can make it difficult to formulate palatable and acceptable drug products. This is particularly problematic in pediatric and geriatric populations, where the taste or smell of medication can lead to poor patient compliance. Masking the odor of APIs without compromising their therapeutic efficacy or the stability of the formulation requires careful selection of excipients and formulation strategies.
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Pediatric patients present unique challenges in pharmaceutical formulation, particularly when it comes to capsule dosage forms. Children often have different pharmacokinetic profiles, swallowing abilities, and taste preferences compared to adults, making it difficult to design effective and acceptable dosage forms. Hard gelatin capsules and soft gelatin capsules, which are commonly used for adult formulations, may not be suitable for pediatric use due to size, taste, and ease of administration concerns. Moreover, the need for accurate dosing, safety, and palatability complicates the development process for pediatric capsules.
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