Excipients are typically the major components in a drug product. Many formulations contain only a... more Excipients are typically the major components in a drug product. Many formulations contain only a small percentage of the active drug molecules. Pharmaceutical excipients or additives are compounds added to the inished drug products to serve a speciic function. They are added to increase bulk, aid manufacturing, improve stability, enhance drug delivery and targeting, and modify drug safety or pharmacokinetic proile. Ingredients that are used during drug product manufacturing but may not be present in the inished drug product are also considered excipients (examples include water for lyophilized products, and inert gases in the head space of containers) (1). In recent years the "functionality" of excipients in a dosage form (similar to pharmacological activity of an active pharmaceutical ingredient or drug substance) has been recognized by USP & European Pharmacopoeia. Many excipient monographs do not address this aspect of excipient functionality or its control. Excipients are traditionally referred to as inactive or inert ingredients to distinguish them from active pharmaceutical ingredients. Excipients may not be as inert as the term inactive suggests. Due to safety issues, several countries have restrictions on the type or amount of excipient that can be included in the formulation of parenteral drug product. For example, in Japan, the U.S., and the E.U., amino mercuric chloride or thiomersal use is prohibited, despite the presence of these excipients in products in other regions (2). Excipients are the integral part of pharmaceutical products development to achieve desired product proile (stability and eficacy). This review deals with understanding of the physicochemical properties of excipients used in parenteral formulation development for solution, suspension and lyophilized drug products. However, inspite of proper excipients selection, judicious use during formulation manufacturing process based on their critical properties is also important to avoid negative effects such as loss of drug solubility, activity and stability. This paper deals with proper selection of excipients in lyophilized drug products which gives high critical temperature, good bulking properties avoiding melt back and collapse with improved dried product appearance. We have also emphasized on appropriate selection of excipients for solution, suspension injectable dosage forms and linking their physiochemical properties with optimum manufacturing method with suitable case studies. This review will highlight various excipient related issues optimizing product performance with documented references and practical approaches based on scientiic justiication. The reader will gain better understanding of excipients complexity during stability studies and resolving problems with practical approach.
Excipient Selection In Parenteral Formulation Development, Mar 10, 2013
"""Excipients are the integral part of pharmaceutical products development to achieve desired pro... more """Excipients are the integral part of pharmaceutical products development to achieve desired product profile(stability and efcacy). This review deals with understanding of the physicochemical properties of excipients used
in parenteral formulation development for solution, suspension and lyophilized drug products. However, in spite of proper excipients selection, judicious use during formulation manufacturing process based on their critical properties is also important to avoid negative effects such as loss of drug solubility, activity and stability. This paper deals with proper selection of excipients in lyophilized drug products which gives high critical temperature, good bulking properties avoiding melt back and collapse with improved dried product appearance. We have also emphasized on appropriate selection of excipients for solution, suspension injectable dosage forms and linking their physiochemical properties with optimum manufacturing method with suitable case studies. This review will highlight various excipient related issues optimizing product performance with documented references and practical approaches based on scientific justification. The reader will gain better understanding of excipients complexity during stability studies and resolving problems with practical approach."
Excipients are typically the major components in a drug product. Many formulations contain only a... more Excipients are typically the major components in a drug product. Many formulations contain only a small percentage of the active drug molecules. Pharmaceutical excipients or additives are compounds added to the inished drug products to serve a speciic function. They are added to increase bulk, aid manufacturing, improve stability, enhance drug delivery and targeting, and modify drug safety or pharmacokinetic proile. Ingredients that are used during drug product manufacturing but may not be present in the inished drug product are also considered excipients (examples include water for lyophilized products, and inert gases in the head space of containers) (1). In recent years the "functionality" of excipients in a dosage form (similar to pharmacological activity of an active pharmaceutical ingredient or drug substance) has been recognized by USP & European Pharmacopoeia. Many excipient monographs do not address this aspect of excipient functionality or its control. Excipients are traditionally referred to as inactive or inert ingredients to distinguish them from active pharmaceutical ingredients. Excipients may not be as inert as the term inactive suggests. Due to safety issues, several countries have restrictions on the type or amount of excipient that can be included in the formulation of parenteral drug product. For example, in Japan, the U.S., and the E.U., amino mercuric chloride or thiomersal use is prohibited, despite the presence of these excipients in products in other regions (2). Excipients are the integral part of pharmaceutical products development to achieve desired product proile (stability and eficacy). This review deals with understanding of the physicochemical properties of excipients used in parenteral formulation development for solution, suspension and lyophilized drug products. However, inspite of proper excipients selection, judicious use during formulation manufacturing process based on their critical properties is also important to avoid negative effects such as loss of drug solubility, activity and stability. This paper deals with proper selection of excipients in lyophilized drug products which gives high critical temperature, good bulking properties avoiding melt back and collapse with improved dried product appearance. We have also emphasized on appropriate selection of excipients for solution, suspension injectable dosage forms and linking their physiochemical properties with optimum manufacturing method with suitable case studies. This review will highlight various excipient related issues optimizing product performance with documented references and practical approaches based on scientiic justiication. The reader will gain better understanding of excipients complexity during stability studies and resolving problems with practical approach.
Excipient Selection In Parenteral Formulation Development, Mar 10, 2013
"""Excipients are the integral part of pharmaceutical products development to achieve desired pro... more """Excipients are the integral part of pharmaceutical products development to achieve desired product profile(stability and efcacy). This review deals with understanding of the physicochemical properties of excipients used
in parenteral formulation development for solution, suspension and lyophilized drug products. However, in spite of proper excipients selection, judicious use during formulation manufacturing process based on their critical properties is also important to avoid negative effects such as loss of drug solubility, activity and stability. This paper deals with proper selection of excipients in lyophilized drug products which gives high critical temperature, good bulking properties avoiding melt back and collapse with improved dried product appearance. We have also emphasized on appropriate selection of excipients for solution, suspension injectable dosage forms and linking their physiochemical properties with optimum manufacturing method with suitable case studies. This review will highlight various excipient related issues optimizing product performance with documented references and practical approaches based on scientific justification. The reader will gain better understanding of excipients complexity during stability studies and resolving problems with practical approach."
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Papers by S Pramanick
in parenteral formulation development for solution, suspension and lyophilized drug products. However, in spite of proper excipients selection, judicious use during formulation manufacturing process based on their critical properties is also important to avoid negative effects such as loss of drug solubility, activity and stability. This paper deals with proper selection of excipients in lyophilized drug products which gives high critical temperature, good bulking properties avoiding melt back and collapse with improved dried product appearance. We have also emphasized on appropriate selection of excipients for solution, suspension injectable dosage forms and linking their physiochemical properties with optimum manufacturing method with suitable case studies. This review will highlight various excipient related issues optimizing product performance with documented references and practical approaches based on scientific justification. The reader will gain better understanding of excipients complexity during stability studies and resolving problems with practical approach."
in parenteral formulation development for solution, suspension and lyophilized drug products. However, in spite of proper excipients selection, judicious use during formulation manufacturing process based on their critical properties is also important to avoid negative effects such as loss of drug solubility, activity and stability. This paper deals with proper selection of excipients in lyophilized drug products which gives high critical temperature, good bulking properties avoiding melt back and collapse with improved dried product appearance. We have also emphasized on appropriate selection of excipients for solution, suspension injectable dosage forms and linking their physiochemical properties with optimum manufacturing method with suitable case studies. This review will highlight various excipient related issues optimizing product performance with documented references and practical approaches based on scientific justification. The reader will gain better understanding of excipients complexity during stability studies and resolving problems with practical approach."