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Finding parenteral solutions to meet formulator needs
November 9, 2016
By: Dr. Elham
Parenteral preparations are defined as solutions, suspensions, emulsions for injection or infusion, powders for injection or infusion, gels for injection and implants.1 They are sterile preparations intended to be administrated directly into the systemic circulation in human or animal body. Like any pharmaceutical dosage forms, they are required to meet the pharmaceutical quality standards as described in pharmacopeias and to be safe for the intended purpose of use.1,2,3 In addition to being sterile, parenteral preparations must be pyrogen-free. Sterility can be achieved by different processes of sterilization that should be appropriate to the formulations4 while the pyrogen-free aspect will require, if no depyrogenation process is used during the preparation of the sterile drug products, the use of pyrogen-free pharmaceutical ingredients—drug substances or API (Active Pharmaceutical Ingredient) and excipients. They are usually supplied in single dose glass or plastic containers. PVC is nowadays less recommended. More and more they are being supplied in pre-filled syringes or pens to facilitate ease of use.1 This article will describe the main challenges encountered during the formulation of parenteral preparations, as well as solutions meeting the formulator’s needs. Properties of parenteral preparations Parenteral preparations are intended to be administrated through the human or animal body, either by direct injections, for example, bolus intravenous (IV), intramuscular (IM) or subcutaneous (SC), or by infusion with a controlled infusion rate or by direct implantation through IM or SC. They must meet the following minimum compendia criteria1,2,3:
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