Formulation for liquid pharmaceutical applications requires a meticulous blend of ingredients and production know-how. A comprehensive portfolio of excipients for liquid formulation addressing multiple applications is needed for the many challenges faced by drug manufacturers, demanding considerable expertise and supplier partnership.
Patient compliance with injectable drugs is known to be lower than other dosage forms, particularly for chronic diseases or conditions. Reducing the number of injections required while maintaining efficacy of therapeutics and extending release kinetics is a challenge. Developers seek to address these needs by developing sustained release formulations.
Excipients used in final formulation of injectable drugs need to meet regulatory guidelines. It is important to choose a supplier able to ensure that their raw materials meet these guidelines. Manufactured with the right quality levels to use as excipients, these formulation components help drug manufacturers ensure compliance in both clinical trials and commercial manufacture of drugs. Sustained release of small molecule injectables can be enabled with biodegradable polymers, helping to optimize and control the release kinetics.
Overcoming increasingly complex obstacles in small molecule drug manufacturing requires a strategic approach to processing, formulation, regulatory compliance, raw material quality, and supplier selection.
Solid dose challenges include API solubility and final formulation API stability, controlling total cost of manufacturing, and creating a robust, homogeneous tablet free of complications during packaging or storage.
Drug products must be free from bacteria and other microorganisms to ensure patient safety, requiring expert use of aseptic filtration for pharmaceutical products that cannot be terminally sterilize.
The final fill process is a critical aspect of drug manufacturing, demanding careful risk mitigation in order to ensure that safe therapeutic drug products are provided to patients.
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