Tag: Capsule tamper-evidence

Issues with Formulating Drugs with Strong Oxidative Potential Addressing Issues with Formulating Drugs with Strong Oxidative Potential Context Drugs with strong oxidative potential pose significant challenges during the formulation process, especially when encapsulated in soft gelatin capsules or other dosage forms. These drugs are highly susceptible to degradation due to oxidation, which can lead to…

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Limited Options for Shell Materials That Are Free from Animal Origin Addressing the Limited Options for Shell Materials That Are Free from Animal Origin Context The use of soft gelatin capsules and hard gelatin capsules is a common method for delivering pharmaceuticals, particularly for APIs that require solubilization or protection from the environment. However, the…

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Problems with Encapsulating Drugs with Variable Particle Size Distribution Addressing Problems with Encapsulating Drugs with Variable Particle Size Distribution Context The encapsulation of drugs with variable particle size distribution (PSD) is a common challenge in pharmaceutical formulations, especially when preparing capsules for solid oral dosage forms. The size and uniformity of the particles in the…

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Lack of Standardization in Lipid-Based Excipient Formulations Addressing the Lack of Standardization in Lipid-Based Excipient Formulations Context Lipid-based excipients, such as oils, fats, and lipids, play a critical role in the formulation of soft gelatin capsules, particularly for hydrophobic active pharmaceutical ingredients (APIs). These excipients help to solubilize poorly soluble drugs, enhance bioavailability, and provide…

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Challenges in Optimizing Shell Composition for Faster Disintegration Addressing the Challenges in Optimizing Shell Composition for Faster Disintegration Context The disintegration time of soft gelatin capsules plays a crucial role in ensuring that the drug is released effectively and absorbed into the body. A faster disintegration rate is particularly important for drugs that require rapid…

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Difficulty in Encapsulating Oils with High Peroxide Content Addressing the Difficulty in Encapsulating Oils with High Peroxide Content Context 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…

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Problems with Achieving the Required Viscosity for Soft Gelatin Fill Material Addressing Problems with Achieving the Required Viscosity for Soft Gelatin Fill Material Context 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…

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Incompatibility of High-Shear Granulation Processes with Capsule Formulations Addressing the Incompatibility of High-Shear Granulation Processes with Capsule Formulations Context 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…

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Issues with Developing Stable Dispersions for Soft Gelatin Capsules Addressing Issues with Developing Stable Dispersions for Soft Gelatin Capsules Context 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,…

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Difficulty in Masking the Unpleasant Odor of Certain APIs Addressing the Difficulty in Masking the Unpleasant Odor of Certain APIs Context 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,…

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Formulation Development Challenges for Pediatric Capsule Dosage Forms Addressing Formulation Development Challenges for Pediatric Capsule Dosage Forms Context 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…

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Complexity in Designing Formulations for Site-Specific Drug Release Addressing the Complexity in Designing Formulations for Site-Specific Drug Release Context Site-specific drug release is a challenging but critical aspect of pharmaceutical formulation, especially for drugs that require targeted delivery to specific regions of the gastrointestinal tract or other targeted areas of the body. The complexity of…

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