Unlocking Pharma's Secrets: Your Ultimate Guide to Pharmaceutical Success!
The orange peel effect refers to an uneven, rough, or dimpled texture on the surface of film-coated tablets. This defect resembles the skin of an orange and occurs due to improper drying, incorrect spray parameters, or formulation inconsistencies during the coating process. Preventing this issue is essential for achieving a smooth and uniform coating finish, which is critical for product quality and aesthetics.
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Developing tablets for pediatric use presents unique challenges, including dose flexibility, taste masking, ease of swallowing, and safety. Children have different physiological responses, difficulty swallowing solid dosage forms, and a preference for palatable medications. Pediatric formulations must be age-appropriate, palatable, and adaptable for varying weight-based dosages.
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Tablet sticking occurs when coated tablets adhere to each other or to the walls of the coating pan during the film coating process. This issue compromises the quality of the coating, leading to uneven surfaces, defects, and reduced product quality. Sticking often results from improper process parameters, formulation issues, or environmental factors, making it essential to identify and address the root causes.
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Enteric-coated tablets are designed to protect APIs from gastric degradation and ensure site-specific drug release. While traditional enteric coatings enable drug release in the intestine, newer formulations are being developed to provide dual pH-release profiles, allowing partial drug release in the stomach and complete release in the intestines. This is particularly useful for drugs requiring immediate action in the stomach while maintaining extended or targeted release in the intestine.
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The spray rate is a critical parameter in the tablet coating process, determining the uniformity, consistency, and quality of the coating layer. An optimized spray rate ensures that the coating is evenly distributed across the tablets, preventing issues like over-wetting, rough surfaces, or inadequate coverage. Proper control of the spray rate also minimizes material waste and ensures efficient coating operations.
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Film coating is an essential step in tablet manufacturing, improving drug stability, taste masking, and controlled drug release. However, one of the most common issues faced during coating is tablet sticking and adhesion, leading to poor-quality coatings, inconsistent drug release, and production inefficiencies.
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Particle size reduction is a critical step in the formulation of high-dose active pharmaceutical ingredient (API) tablets. Reducing the particle size of the API enhances its surface area, improving solubility, dissolution rate, and bioavailability. However, in high-dose formulations, particle size reduction must be carefully managed to avoid issues such as poor flowability, segregation, or reduced compressibility, which can affect the final tablet quality and manufacturability.
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Coating of sustained release (SR) tablets plays a critical role in controlling drug release, protecting active pharmaceutical ingredients (APIs), and enhancing patient compliance. However, heat sensitivity of certain APIs and excipients presents significant challenges, particularly when using thermal curing, solvent evaporation, or high-temperature drying.
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Core erosion during the tablet coating process is a significant issue that can lead to loss of drug content, reduced mechanical strength, irregular drug release, and aesthetic defects. This occurs when the core loses its structural integrity due to excessive moisture, mechanical stress, or improper formulation of the coating suspension. Addressing this problem is crucial to ensuring a stable, uniform, and effective coated tablet.
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Tablet coating plays a critical role in pharmaceutical manufacturing by enhancing stability, patient compliance, taste masking, and drug release control. However, achieving uniform coating on irregularly shaped tablets presents significant challenges due to uneven surface geometry, variable surface area, and inconsistent coating distribution.
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Osmotic drug delivery systems (ODDS) are advanced formulations designed to control the release of drugs by utilizing osmotic pressure. These systems ensure a consistent drug release rate, independent of environmental factors such as pH or gastrointestinal motility. ODDS are especially useful for sustained-release formulations, improving therapeutic efficacy and patient compliance.
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Active Pharmaceutical Ingredients (APIs) prone to oxidation pose a significant challenge in tablet formulation, leading to reduced potency, discoloration, and degradation. Oxidation can be triggered by exposure to oxygen, light, humidity, and excipient interactions. Ensuring the stability of such APIs requires a strategic approach to formulation, packaging, and storage.
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