R&D

Formulation | Quality by Design

Quality by Design (QbD) in Topical Formulations
ByPharma Lesson March 29, 2025March 29, 2025 Reading Time: 2 minutes

In topical pharmaceutical development, achieving batch-to-batch consistency, therapeutic efficacy, and regulatory compliance requires a Quality by Design (QbD) framework. A well-defined design space based on Critical Material Attributes (CMAs), Critical Process Parameters (CPPs), and Critical Quality Attributes (CQAs) ensures an optimized, scalable, and reproducible formulation. Identifying CMAs in Topical Formulations API Attributes: Excipient Functionality: Defining…

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Formulation

Key Considerations for API Source Change in Formulation
ByPharma Lesson March 16, 2025March 16, 2025 Reading Time: 2 minutes

Changing the API source requires evaluating its impact on safety, efficacy, stability, and manufacturability. Below are the key factors to assess: Physicochemical Properties Dissolution & Bioavailability Stability Considerations Regulatory & Compliance Manufacturing & Process Impact In-vivo Considerations Risk Assessment & Final Decision Conclusion API source changes demand scientific, regulatory, and process evaluations to prevent any…

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Pharmaceutical Development | Regulatory Affairs and Compliance

Regulatory Strategies for Excipient Grade Changes Across Global Markets
ByPharma Lesson March 14, 2025March 14, 2025 Reading Time: 2 minutes

When changing the grade of an excipient for different markets the regulatory approach depends on whether the change impacts safety, quality, or efficacy of the drug product. Here’s how to address it for key regulatory agencies: USFDA Filing Type: Documentation: MHRA & EMA Variation Classification: Documentation: MENA Region (Saudi FDA, UAE, Egypt, etc.) Regulatory Approach:…

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Formulation

SUPAC Guidance on Qualitative Changes in Excipients
ByPharma Lesson March 14, 2025March 14, 2025 Reading Time: 2 minutes

SUPAC Guidance on Qualitative Changes The USFDA SUPAC (Scale-Up and Post-Approval Changes) guidance categorizes formulation changes based on their impact on product performance. A qualitative change refers to the replacement or removal of an excipient, classified as a Level 3 change, which is considered major and requires regulatory approval. Key Regulatory Requirements for Level 3…

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Bioequivalence | Formulation

Is a Bioequivalence (BE) Study Needed When Replacing Crospovidone with Croscarmellose?
ByPharma Lesson March 14, 2025March 14, 2025 Reading Time: 2 minutes

A BE study may or may not be required, depending on several factors. Here’s a structured approach to determine whether regulatory agencies like the FDA or EMA would require a BE study for this type of qualitative formulation change: Regulatory Perspective on Excipients in Bioequivalence Regulatory agencies consider excipients when evaluating bioequivalence, especially when they…

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Formulation

Overcoming Solubility Challenges in Pharmaceutical Formulation
ByPharma Lesson March 7, 2025March 7, 2025 Reading Time: 2 minutes

Today, let’s dive into the intricate world of overcoming solubility challenges in drug formulation. Join me as we explore the hurdles posed by poor solubility and the ingenious strategies formulated by scientists to tackle this pervasive issue. Solubility Challenges Formulation Strategies Nanosuspensions: Solid Dispersions: Cyclodextrin Complexation: Overcoming solubility challenges is pivotal in developing effective therapies….

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