Tips for Tablets

Pre-formulation studies are a critical phase in the development of pharmaceutical tablets. These studies involve assessing the physical and chemical properties of the active pharmaceutical ingredient (API) and excipients, which serve as the foundation for successful tablet formulation. The insights gained during pre-formulation can guide decisions regarding the choice of excipients, tablet design, and the selection of manufacturing processes to ensure that the final product meets the required quality attributes, such as stability, dissolution, and bioavailability. This article explores the significance of pre-formulation studies in tablet development and how they help overcome common formulation challenges.
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Friability is a critical factor in tablet formulation, referring to the tendency of tablets to break or crumble under stress during handling, transport, and storage. A high friability rate indicates poor tablet strength and can lead to product instability, reduced shelf-life, and inconsistent dosing. Achieving low friability is crucial for ensuring that tablets maintain their integrity and are capable of withstanding physical stresses encountered during production and post-production stages. This article explores the root causes of friability in tablets and provides practical strategies for minimizing it during development to ensure high-quality, durable tablets.
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Orally disintegrating tablets (ODTs) are designed to dissolve or disintegrate rapidly in the mouth without the need for water, offering an easy-to-administer option for patients, especially those with swallowing difficulties. ODTs are commonly used for pediatric, geriatric, and certain psychiatric medications, as they provide a convenient alternative to traditional tablets or capsules. However, formulating ODTs presents several challenges, including ensuring rapid disintegration, maintaining stability, and providing adequate taste masking. This article explores the common formulation challenges in ODTs and offers strategies for overcoming them to ensure the production of high-quality, effective products.
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Sustained release (SR) tablets are designed to release the active pharmaceutical ingredient (API) over an extended period, allowing for more consistent therapeutic effects with fewer doses. Achieving consistent release profiles in SR tablets is critical to ensure that the drug is released at a controlled rate, providing therapeutic benefits throughout the dosing period. However, formulating SR tablets presents several challenges, including variability in drug release, degradation of the API, and maintaining stability over time. This article discusses the common challenges in formulating SR tablets and presents practical solutions to achieve consistent release profiles, while ensuring product quality, stability, and compliance with regulatory requirements.
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Sugar coating is a popular tablet formulation technique that provides a protective layer around the active pharmaceutical ingredient (API). This coating improves tablet appearance, masks unpleasant taste, and protects the API from environmental factors. However, one common challenge in the formulation of sugar-coated tablets is the overuse of coating polymers. Overuse of coating materials can lead to several issues, including prolonged disintegration times, reduced bioavailability, and increased manufacturing costs. This article explores the consequences of excessive use of coating polymers in sugar-coated tablets and offers practical solutions to optimize the coating process while ensuring the stability and efficacy of the final product.
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The stability of active pharmaceutical ingredients (APIs) in film-coated tablet formulations is a key factor in ensuring the safety, efficacy, and shelf-life of the final product. Film coating is a widely used technique in pharmaceutical tablet formulation to protect the drug from environmental factors, enhance aesthetics, and control the release profile. However, the stability of the API during the formulation and storage process remains a challenge. Factors such as moisture, temperature, light, and the chemical interactions between the API and excipients can affect the stability of the drug, leading to degradation or loss of potency. This article outlines the challenges associated with API stability in film-coated tablets and offers strategies to mitigate these risks while ensuring product quality.
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Solubility is one of the most significant challenges in pharmaceutical formulation, particularly when developing immediate release (IR) tablets. The solubility of the active pharmaceutical ingredient (API) directly impacts its bioavailability and therapeutic efficacy. For poorly soluble drugs, achieving adequate solubility is essential for ensuring that the drug is absorbed effectively in the gastrointestinal tract. However, solubility enhancement for IR tablets presents unique challenges, especially when formulating drugs with low water solubility. To address this, pharmaceutical manufacturers employ a variety of methods to enhance the solubility and dissolution of APIs, which are key to achieving rapid therapeutic effects in patients.
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