Tag: Capsule formulation development

Limited Compatibility of Acid-Sensitive APIs with Hard Gelatin Capsules Addressing the Limited Compatibility of Acid-Sensitive APIs with Hard Gelatin Capsules Context Hard gelatin capsules are commonly used for drug delivery, but when the active pharmaceutical ingredient (API) is acid-sensitive, compatibility with the gelatin shell becomes a challenge. Acid-sensitive APIs may degrade or lose efficacy when…

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Inconsistencies in Fill Weight Due to Hygroscopic Ingredients Addressing Inconsistencies in Fill Weight Due to Hygroscopic Ingredients Context Hygroscopic ingredients, such as certain excipients or active pharmaceutical ingredients (APIs), are prone to absorbing moisture from the surrounding environment. This moisture absorption can cause the weight and volume of these ingredients to change, leading to inconsistencies…

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Difficulty in Achieving Rapid Onset of Action in Hard Gelatin Capsules Addressing the Difficulty in Achieving Rapid Onset of Action in Hard Gelatin Capsules Context Hard gelatin capsules are widely used for oral drug delivery, but achieving a rapid onset of action in these capsules can be challenging. For certain drugs, the speed at which…

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High Risk of Microbial Contamination in Aqueous-Based Soft Gelatin Formulations Addressing the High Risk of Microbial Contamination in Aqueous-Based Soft Gelatin Formulations Context Aqueous-based formulations, such as those used in soft gelatin capsules containing suspensions, emulsions, or liquid-filled capsules, face significant challenges with microbial contamination. Due to the high moisture content in these formulations, they…

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Lack of Suitable Surfactants for Hydrophobic APIs in Capsule Formulations Overcoming the Lack of Suitable Surfactants for Hydrophobic APIs in Capsule Formulations Context Hydrophobic active pharmaceutical ingredients (APIs) pose significant challenges in capsule formulations, particularly when attempting to achieve adequate solubility and bioavailability. Surfactants are commonly used to enhance the solubility of hydrophobic drugs by…

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Variations in Capsule Dissolution Behavior Due to Excipients Grade Variability Addressing Variations in Capsule Dissolution Behavior Due to Excipients Grade Variability Context The quality and consistency of excipients are crucial to ensuring the uniformity and reliability of pharmaceutical formulations, especially in soft gelatin capsules. However, variations in excipient grades can significantly impact capsule dissolution behavior,…

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Difficulty in Determining Optimal Capsule Fill Temperature for Soft Gelatin Capsules Overcoming the Difficulty in Determining Optimal Capsule Fill Temperature for Soft Gelatin Capsules Context Soft gelatin capsules are widely used for encapsulating a variety of pharmaceutical formulations, including liquids, semisolids, and powders. However, determining the optimal fill temperature for soft gelatin capsules can be…

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High Variability in Drug Release Profiles During Stability Studies Addressing High Variability in Drug Release Profiles During Stability Studies Context Stability studies are an essential part of pharmaceutical development, providing critical data on how a drug formulation performs over time under various environmental conditions. However, achieving consistent drug release profiles during these studies can be…

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Limitations in Shell Material Customization for Specific APIs Overcoming Limitations in Shell Material Customization for Specific APIs Context The development of soft gelatin capsules requires careful selection and customization of the shell material to ensure optimal performance, stability, and drug release for specific active pharmaceutical ingredients (APIs). However, there are inherent limitations in customizing the…

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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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