Tag: USFDA guidelines

Difficulty in maintaining proper alignment of carton inserts.

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Difficulty in maintaining proper alignment of carton inserts. Difficulty in maintaining proper alignment of carton inserts Introduction: In the pharmaceutical industry, the proper alignment of carton inserts plays a crucial role in ensuring that medications are packaged correctly and are user-friendly for healthcare providers and patients. Carton inserts provide necessary information about the medication, including…

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Capsules (Hard & Soft Gelatin), Solid Oral Dosage Forms

Problems with monitoring moisture migration within capsule shells.

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Problems with monitoring moisture migration within capsule shells. Problems with Monitoring Moisture Migration Within Capsule Shells Introduction: In the pharmaceutical industry, ensuring the integrity and stability of solid oral dosage forms is paramount. Capsules, whether hard or soft gelatin, are widely used due to their ease of administration and ability to encapsulate a variety of…

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Capsules (Hard & Soft Gelatin), Solid Oral Dosage Forms

Managing Hardness Failures in Bilayer Tablets During Testing

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Managing Hardness Failures in Bilayer Tablets During Testing Managing Hardness Failures in Bilayer Tablets During Testing Introduction: In the pharmaceutical industry, bilayer tablets have emerged as a sophisticated solution for delivering multiple drugs or varied release profiles within a single dosage form. This innovation not only enhances patient compliance but also optimizes therapeutic efficacy by…

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Solid Dosage form, Tablets

Challenges in measuring residual moisture in soft gelatin capsules.

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Challenges in measuring residual moisture in soft gelatin capsules. Challenges in measuring residual moisture in soft gelatin capsules. Introduction: The pharmaceutical industry is constantly evolving, with a focus on precision, quality, and compliance. Soft gelatin capsules, widely used for their ease of consumption and ability to encapsulate both aqueous and oily solutions, are highly sensitive…

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Capsules (Hard & Soft Gelatin), Solid Oral Dosage Forms

Addressing Brittleness in Sugar-Coated Tablets Under Freeze-Thaw Cycles

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Addressing Brittleness in Sugar-Coated Tablets Under Freeze-Thaw Cycles Addressing Brittleness in Sugar-Coated Tablets Under Freeze-Thaw Cycles Introduction: Sugar-coated tablets are a popular solid dosage form in the pharmaceutical industry due to their aesthetic appeal and ability to mask the taste of active pharmaceutical ingredients (APIs). However, the stability of these tablets can be significantly challenged…

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Solid Dosage form, Tablets

Difficulty in ensuring consistent performance of capsule sealing equipment.

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Difficulty in ensuring consistent performance of capsule sealing equipment. Difficulty in ensuring consistent performance of capsule sealing equipment. Introduction: In the pharmaceutical industry, the use of capsules as a dosage form is widespread due to their ease of production, patient compliance, and ability to encapsulate a variety of drugs. The capsule sealing process is a…

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Capsules (Hard & Soft Gelatin), Solid Oral Dosage Forms

Troubleshooting Residual Binder Issues in Granulation Equipment During Validation

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Troubleshooting Residual Binder Issues in Granulation Equipment During Validation Troubleshooting Residual Binder Issues in Granulation Equipment During Validation Introduction: In the pharmaceutical industry, ensuring the quality and efficacy of solid dosage forms like tablets is paramount. Granulation is a critical process in tablet manufacturing, where powders are agglomerated to form granules, enhancing flowability and compressibility…

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Solid Dosage form, Tablets

Troubleshooting Over-Drying in Coated Tablets During Finishing

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Troubleshooting Over-Drying in Coated Tablets During Finishing Troubleshooting Over-Drying in Coated Tablets During Finishing Introduction: The pharmaceutical industry is continually innovating to ensure the highest quality of products. Among the various dosage forms, coated tablets are one of the most prevalent, owing to their aesthetic appeal, ease of swallowing, and controlled release capabilities. However, the…

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Solid Dosage form, Tablets

Validating Rinse Sampling Procedures in Cleaning Validation for Film-Coated Tablets

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Validating Rinse Sampling Procedures in Cleaning Validation for Film-Coated Tablets Validating Rinse Sampling Procedures in Cleaning Validation for Film-Coated Tablets Introduction: In the pharmaceutical industry, ensuring the cleanliness of manufacturing equipment is crucial, especially when producing film-coated tablets. Cleaning validation, particularly rinse sampling procedures, plays a pivotal role in confirming that any residues from previous…

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Solid Dosage form, Tablets

Preventing Granule Breakage During Fluid Bed Drying

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Preventing Granule Breakage During Fluid Bed Drying Preventing Granule Breakage During Fluid Bed Drying Introduction: In the pharmaceutical industry, fluid bed drying is a critical process in the production of solid dosage forms, particularly tablets. This method is favored for its efficiency in drying granules, which are the intermediate product before compression into tablets. However,…

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Solid Dosage form, Tablets

Ensuring Compliance with Regulatory Guidelines for Extended Release Tablets

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Ensuring Compliance with Regulatory Guidelines for Extended Release Tablets Ensuring Compliance with Regulatory Guidelines for Extended Release Tablets Introduction: Extended release tablets are a crucial innovation in pharmaceutical dosage forms, designed to release active pharmaceutical ingredients (APIs) over an extended period. This delivery system improves patient adherence, optimizes therapeutic outcomes, and reduces dosing frequency. However,…

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Solid Dosage form, Tablets

Challenges in validating uniform mixing of multi-component powder blends.

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Challenges in validating uniform mixing of multi-component powder blends. Challenges in validating uniform mixing of multi-component powder blends. Introduction: In the pharmaceutical industry, ensuring the uniform mixing of multi-component powder blends is crucial for maintaining the quality and efficacy of solid oral dosage forms, such as capsules and tablets. The uniformity of the blend directly…

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Capsules (Hard & Soft Gelatin), Solid Oral Dosage Forms