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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Raw Materials Used in Parenterals Formulation |authorSTREAM

They must meet the following minimum com-pendia criteria: Includes drugs in solution, suspension, gel or ointment meant for administration in to the corneal surface of the eye. Pharma recruitment news Education Website.

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.

When these are used as vehicles,then formulations should not be diluted with water as precipitation may occur. When the use of a stabilizer is justified for instance the 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.

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Used to prevent degradation and denaturation of injectable protein formulations such as insulin. Go to Application Have a question? The pH is one of the critical aspects of parenteral preparations which should have a pH close to the physiological one.

Email or Phone Password Forgot account? Alcohol causes pain and tissue damage at the site of injection. Finally the process of the parenrerals 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 stability of parenteraals drug substance is another critical point that a formulator can face during the development of the formulation. Pharmacology Notes Education Website. Elham Blouet, Pharmacist with several years of experience in industrial pharma companies and health authorities agency.

As most drugs are weak acids and bases. In order to decrease drug solubility for improving its stabilitywe can: Antioxidants can be classified formuation. 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.

Modification of the drug may occur inside the body or parentwrals the reconstitution of the injection. These are contrast media having radioactive iodine, chromium, technetium, iron etc meant for evaluation of organ functions.

Antioxidants prevent or inhibit oxidation of drug. Study material for Pharma students updated their status. To disperse a water insoluble drug as a colloidal dispersion For wetting powders For better syringe ability Prevent crystal growth in suspensions For solubilizing steroids and fat soluble vitamins. I am a Pharmacist. Automatically changes to Flash or non-Flash embed.

Used to protect drug against loss of activity caused by stress that is introduced by manufacturing process. They should meet the pharmaceutical quality standards as described in pharmacopeias and ICH guidelines and also ensure the clinical tolerance fofmulation well as to be safe for the intended purpose of use.

Antioxidants can be classified as: Sunday, November 20, When drug substances are not or, 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. Formulation of parenteral preparations the formulation of parenteral preparations need careful planning ,thorough knowledge of medicaments and adjuvants to be used.


Chemistry Masala Personal Blog. While selecting the additives ,care must be taken that they should be compatible both physical and chemical with the entire formulation. To make the formulation isotonic. Prepared by following methods: The presentation is successfully added In Your Favorites. The wetting agents are used to reduce the interfacial tension between the solid particles and the liquid, so as to prevent the formulation of lumps.

Keep up with our latest articles, news and events. Fixed vegetable oils are used Prolong drug release at site of administration can be achieved pafenterals converted to oily suspension. Metal ions enhance the oxidation process ,hence these are to be turned off by chelating agents PowerPoint Presentation: Plus, get special offers and more delivered to your inbox. Metal ions enhance the oxidation process ,hence these are to be turned off by chelating agents.

With regards to solutions and emulsions, the drug substances should be soluble and remain soluble during the entire shelf-life of the drug products. It prevents loss of API from adsorption on process equipment.

Parenteral Preparations, Challenges in Formulations

Drug formulated into injectable suspensions because: It is done because osmotic pressure changes and resultant exchange of ionic species across RBC membrane causes many problems. It is the ability of a solid material to exist in more than one form or crystal structure. Parenteral preparations are sterile and pyrogen-free preparations intended to be administered directly into the systemic circulation in human or animal body.

The excess use of adjuvants in parenteral products should be avoided as some of these may interfere with the drug. Sections of this page.