Tag: Capsule Quality Control

Difficulty in Achieving Desired Uniformity in Bilayer Capsules Overcoming the Difficulty in Achieving Desired Uniformity in Bilayer Capsules Context Bilayer capsules are increasingly used in pharmaceutical formulations to combine drugs with different release profiles in a single dosage form. These capsules typically consist of two distinct layers: one for immediate release and one for sustained…

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Poor API Solubility in Lipid-Based Excipients for Soft Gelatin Capsules Overcoming Poor API Solubility in Lipid-Based Excipients for Soft Gelatin Capsules Context Formulating lipid-based excipients in soft gelatin capsules can significantly enhance the solubility and bioavailability of hydrophobic active pharmaceutical ingredients (APIs). However, many APIs have poor solubility in lipid-based excipients, which can impede the…

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Limited Availability of Suitable Solvents for Poorly Soluble Drugs Overcoming the Limited Availability of Suitable Solvents for Poorly Soluble Drugs Context Many active pharmaceutical ingredients (APIs) exhibit poor solubility in conventional solvents, which can significantly affect the formulation and bioavailability of the drug. This is particularly challenging when developing soft gelatin capsules, as achieving sufficient…

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High Cost of Pilot-Scale Formulation Development for Soft Gelatin Capsules Overcoming the High Cost of Pilot-Scale Formulation Development for Soft Gelatin Capsules Context Developing a soft gelatin capsule formulation at the pilot scale can be an expensive process, especially for new drug candidates or novel formulations. The costs associated with pilot-scale development include raw materials,…

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Challenges in Selecting Optimal Diluents for Hard Gelatin Capsules Addressing Challenges in Selecting Optimal Diluents for Hard Gelatin Capsules Context Diluents, also known as fillers, are critical excipients in hard gelatin capsule formulations. They are used to increase the volume of the capsule and ensure that the correct dose of the active pharmaceutical ingredient (API)…

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Difficulty in Formulating Suspensions for Encapsulation in Soft Gelatin Capsules Overcoming the Difficulty in Formulating Suspensions for Encapsulation in Soft Gelatin Capsules Context Formulating suspensions for encapsulation in soft gelatin capsules presents unique challenges, particularly when dealing with poorly soluble active pharmaceutical ingredients (APIs). Suspensions are formulations in which the API is dispersed in a…

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Issues with Encapsulating Volatile Compounds Overcoming Issues with Encapsulating Volatile Compounds in Soft Gelatin Capsules Context Encapsulating volatile compounds in soft gelatin capsules presents unique challenges due to their tendency to evaporate, degrade, or alter the properties of the capsule shell. Volatile compounds are often essential for the therapeutic action of certain drugs, such as…

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Constraints on Shell Thickness for Soft Gelatin Capsules with Low Drug Content Addressing Constraints on Shell Thickness for Soft Gelatin Capsules with Low Drug Content Context Soft gelatin capsules are commonly used for drug delivery, but they face challenges when the API content is low. In cases where the active pharmaceutical ingredient (API) content is…

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Problems with Achieving Targeted Drug Release Profiles in Hard Gelatin Capsules Overcoming Problems with Achieving Targeted Drug Release Profiles in Hard Gelatin Capsules Context Achieving the desired drug release profile in hard gelatin capsules is a significant challenge in pharmaceutical formulation development. The release profile of a drug is crucial to its therapeutic effectiveness, and…

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Inadequate Studies for Drug-Excipient Interaction During Development Addressing Inadequate Studies for Drug-Excipient Interaction During Development Context Drug-excipient interactions can significantly impact the stability, solubility, bioavailability, and release profile of a pharmaceutical product. However, inadequate studies on these interactions during the drug development phase can lead to formulation failures, delayed product approval, or safety issues. It…

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Formulation Instability Due to Polymorphic Changes in API Overcoming Formulation Instability Due to Polymorphic Changes in API Context Polymorphism in pharmaceuticals refers to the ability of a compound to exist in different crystalline forms, known as polymorphs. The polymorphic form of an active pharmaceutical ingredient (API) can significantly impact its solubility, stability, dissolution rate, and…

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Problems with Achieving the Desired Bioavailability in Lipid-Based Formulations Overcoming Problems with Achieving the Desired Bioavailability in Lipid-Based Formulations Context Lipid-based formulations have gained popularity for improving the bioavailability of poorly water-soluble active pharmaceutical ingredients (APIs). However, achieving the desired bioavailability in these formulations can be challenging. Lipid-based systems, such as soft gelatin capsules containing…

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