Formulation of parenteral preparations the formulation of parenteral preparations need careful planning,thorough knowledge of medicaments and adjuvants to. Introduction. Parenteral preparations are defined as solutions, suspensions, emulsions for injection or infusion, powders for injection or infusion. 2. Chapter 13 – Formulation of Parenteral Products. Objectives. This chapter provides an overview of the development of injectable (parenteral) drug products.
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Parenteral Preparations, Challenges in Formulations
Parenteral preparations are defined as solutions, suspensions, formulagion for injection or infusion, powders for injection or infusion, gels for injection and implants. They are required, like any pharmaceutical dosage formsto meet the pharmaceutical quality standards as described in pharma-copeias and to be safe for the intended purpose of use.
They are usually supplied lf single dose glass or plastic containers PVC nowadays less recommended, or polyolefin or more and more in pre-filled syringes or pens to facilitate the ease of use. Parenteral preparations are intended to be administrated through the human or animal body, either by direct injections for example, bolus intravenous IVintramuscular IM or subcutaneous SC or by infusion with a controlled infusion rate or by formularion implantation through IM or SC.
They must meet the following minimum com-pendia criteria: Parenteral preparations may require the use of excipients that should be biocompatible, be selected for the appropriate use and to be included at the minimum efficient concentration. It should be stressed that excipients should not adversely affect the intended medicinal action of the drug products, nor at the concentration used to cause toxicity or undue local irritation.
The main challenge of all the different parenteral dosage forms is to achieve a good compatibility of the drug substances with the excipients no formation of new impurities either by degradation of the drug substance or formation of new chemical entity between the drug substance and the excipients as well as the compatibility of the preparations with the primary container no leachable or adsorption to container.
With regards to solutions and emulsions, the drug substances should be soluble and remain soluble during the entire shelf-life of the drug products. When drug substances are not soluble, dissolution can be achieved by the use of co-solvents, surfactants, or a soluble pro-drug, or eventually the use of solubility enhancers such as cyclodextrins thanks to the formation of inclusion complex. The pH is one of the critical aspects of parenteral preparations which should have a pH close to the physiological one.
However in certain cases, a compromise should be found between the pH formultion stability of the drug substance such for peptides requiring alkaline pH or proteins at pH close to the isoelectric point and the physiological one. In all cases, large volume preparations LVP, i.
Raw Materials Used in Parenterals Formulation |authorSTREAM
The stability of the drug substance is another critical point that a formulator can face during the development of the formulation. Unstable drug substances will lead to the formation of new impurities jeopardizing the safety of use of the preparations. When the use of a stabilizer is justified for instance parenrerals use of mannitol as free-radical scavenger or cysteine in paracetamol solution for injectionit should be included at the minimum concentration demonstrated to be efficient at release and during the entire shelf-life.
Finally the process of the sterilization should be selected according to the characteristics of the parenteral preparations for instance, heat steam sterilization for aqueous solutions and dry heat for non-aqueous solutionsbut in any case it can be justified by the nature of the primary containers. The efficiency of the selected sterilization process should parengerals demon-strated through validation studies, using the appropriate biological indicators, to ensure an ASL Assurance Sterility level of 10 Roquette has developed a pyrogen-free range of products with high pharmaceutical standards and being biocompatible for the manufacture of parenteral preparations, All these pyrogenfree range of products are obtained from natural and renewable raw materials.
Parenteral preparations are sterile and pyrogen-free preparations intended to be administered directly into the systemic circulation in human or animal body.
They should meet the pharmaceutical quality standards as described in pharmacopeias and ICH guidelines and also ensure the clinical tolerance as formulatioh as to be safe for the intended purpose of use.
Elham Blouet, Pharmacist with several years of experience in industrial pharma companies and health authorities agency. Keep up with our latest articles, news and events.
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