Many drugs are administered in liquid form. Whether injected, infused, consumed orally or applied topically, these therapeutics present unique challenges to formulators. For successful administration via these routes, the active pharmaceutical ingredient (API) must have sufficient solubility and stability. Additional criteria can apply depending on the administration route, such as a defined pH, tonicity or viscosity range to ensure applicability and/or tolerability, optimized taste to improve patient compliance, low bioburden and endotoxin levels or, i.e. for injectables, tested sterility of the final drug product to minimize risk for the patient.
To determine which solution is best suited for a specific API and its formulation requirements, it is important to understand how, and which excipients can help overcome these challenges and key considerations for selecting the best approach.
Solubility is a prerequisite for ensuring bioavailability and the desired therapeutic effect. With an estimated 70–90% of drugs currently in development being poorly water soluble, finding adequate solutions to overcome this challenge is increasingly important and urgent.
Parenteral preparations are high-risk formulations. Because of their route of administration, the potential of contaminations to cause harm is higher compared to other routes of administration such as oral or topical delivery.
Formulating ophthalmic drugs presents unique challenges. Multiple factors must be appropriately balanced including tonicity, pH, and viscosity are necessary to ensure safety, tolerability, and efficacy of the medication. In parallel, low bioburden must be ensured throughout the shelf-life and usage period.
Pharmaceutical formulations, especially liquid and semi-solid formulations, are susceptible to unwanted microbial contamination. If preventive measures are not taken, this will severely impact product shelf life and patent safety. Preservatives may be used to protect formulations from contamination as well as ensure the necessary shelf life.
Manufacturing processes must be designed to bring new therapies to market faster and more cost effectively. A key to workflow efficiency is avoiding process interruptions, quality deviations and operator safety risks.
An unpleasant or bitter tasting oral liquid formulation will result in poor patient compliance, especially among pediatric patients. Enhancing the taste of these formulations requires consideration of many factors including sweetness potency, flavor, mouthfeel, and aftertaste, as well as ensuring safety and stability.
Folates are an essential B vitamin used to promote health and well-being. The stability of folate, including its synthetic form folic acid, however, is compromised by oxidation which presents a challenge for liquid formulations of the vitamin.
Whether you are developing solutions, emulsions or suspensions – we provide high-quality pharmaceutical excipients for liquid formulations.
Free-flowing and easy to handle, our granulated raw materials reduce caking and clumping for enhanced processability, improving both your manufacturing speed and operator safety.
Find high-quality, pure, and reliable raw material solutions to meet your parenteral formulation requirements.
Find high-quality API processing chemicals to enhance API solubility. Our materials can help you with salt formation, co-crystal formation, polymorph screening, and nano-milling.
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Find information on process design considerations at key steps of a parenteral process
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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.
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