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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When drug pparenterals 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.

Automatically changes to Flash or non-Flash embed. In all cases, large volume preparations LVP, i. These are sub visible particles.

It is the ability parenteraos a solid material to exist in more than one form or crystal structure. Used to protect drug against loss of activity caused by stress that is introduced by manufacturing process. Hence,test for pyrogen is done to ensure that water for injection is free from pyrogens.

To make the formulation isotonic. Modification of the drug may occur inside the body or during paretnerals reconstitution of the injection.

Chemistry Masala Personal Blog. In order to decrease parentedals solubility for improving its stabilitywe can: Chelating agents are compounds that can form complexes with metal ions, and in so doing inactivate the catalytic activity of the metal ions in the oxidation process. Sunday, November 20, WordPress Embed Customize Embed.

Raw Materials Used in Parenterals Formulation |authorSTREAM

In thisparent drug is modified. Unstable drug substances will lead to the formation of new impurities jeopardizing the safety of use of the preparations.


Keep up with our latest articles, news and events. However in certain cases, formulatioon compromise should be found between the pH ensuring stability of the drug substance such for peptides requiring alkaline pH or proteins at pH close to the isoelectric point and the physiological one. The excess use of adjuvants in parenteral products should be avoided as some of these may interfere with the drug.

B Non -aqueous vehicles: Metal ions enhance the oxidation process ,hence these are to be turned off by chelating agents. It is done because osmotic pressure changes and resultant exchange of ionic species across RBC membrane causes many problems.

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Parenteral Preparations, Challenges in Formulations

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 direct implantation through IM or SC.

Modified by preparing estersalt or some other derivative in order to: Email or Phone Password Forgot account? Antioxidants prevent or inhibit oxidation of drug. Includes drugs parentedals solution, suspension, gel or ointment meant for administration in to the parentera,s surface of the eye. Plus, get special offers and more delivered to your inbox. The stability of the drug substance is another critical point that a formulator can face during the development of the formulation.

The pH is one of the critical aspects of parenteral preparations which should have a pH close to the physiological one. It prevents loss of API from adsorption on process equipment.


They are usually supplied in 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 defined as solutions, suspensions, emulsions for injection or infusion, powders for injection or infusion, gels for injection and implants.

Parenteral preparations may require the use of excipients that should be biocompatible, be selected for the appropriate use and to be formulatino at the minimum efficient concentration. Roquette has developed a pyrogen-free range of products with high pharmaceutical formuoation and parenteralss biocompatible for the manufacture of parenteral preparations, All these pyrogenfree range of products are obtained from natural and renewable raw materials.

Phenytoin sodium injection contains phenytoin that is solubilized in the water miscible solvent at pH 12 and if it is added to large volumethen precipitation occurs. They are pxrenterals to protect components of the dosage form, which are subject to chemical degradation by oxidation. So, buffers pareterals used to adjust and maintain pH in order to increase stability, solubility, absorption and activity of API.

Study material for Pharma students updated their status. While selecting the additives ,care must be taken that they should be compatible both physical and chemical with the entire formulation.

F suspending ,emulsifying and wetting agents: