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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They should meet the pharmaceutical quality standards as described in pharmacopeias and ICH guidelines and also ensure the clinical tolerance as well as to be safe for the intended purpose of use. Sunday, November 20, These are sub visible particles. Modification of the drug may occur inside the body or during the reconstitution of the injection. Ethyl alcohol is used in the preparation of hydrocortisone injection. Automatically changes to Flash or non-Flash embed. Metal ions enhance the oxidation process ,hence these are to be turned off by chelating agents.

Email or Phone Password Forgot account? F suspending ,emulsifying and wetting 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. Antioxidants can be classified as:.

Parenteral Preparations, Challenges in Formulations

Parenteral Preparations, Challenges in Formulations. Parenteral preparations are sterile and pyrogen-free preparations intended to be administered directly into the parehterals circulation in human or animal body.

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. Formulation of parenteral preparations the formulation of parenteral preparations need careful planning ,thorough knowledge of medicaments and adjuvants to be used. The efficiency of the selected sterilization process should be demon-strated through validation studies, using the appropriate biological indicators, to ensure an ASL Assurance Sterility level of 10 B Non -aqueous vehicles: In order to decrease drug solubility for improving its stabilitywe can: The excess use of adjuvants in parenteral products should be avoided as some of these may interfere with the drug.


Prepared by following methods: Go to Application Have a question? Antioxidants prevent or inhibit oxidation of drug. Sections of this page. Parenteral preparations are defined as solutions, suspensions, emulsions for injection or infusion, powders for injection or infusion, gels for injection and implants.

The wetting agents are used to reduce the interfacial tension between the solid particles and the liquid, so as to prevent the formulation of formulaation. Therefore it is not used commonly.

The stability of the drug substance lf another critical point that a formulator can face during the development of the formulation. 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.

Keep up with our latest articles, news and events. Chemistry Masala Personal Blog. In the preparation of parental productsthe following substances are added to make a stable preparation.

To make the formulation isotonic. They can stabilize proteins both in solution as well as dry state. In thisparent drug is modified. They are added to protect components of the dosage form, which are subject to chemical degradation by oxidation. Study material for Pharma students updated their status. Fixed vegetable oils are used Prolong drug release at site of administration can be achieved when converted to oily suspension.

Alcohol causes pain and tissue damage at the site of injection. Upload from Desktop Single File Upload. In order to view it, please contact the author of the presentation. Unstable drug substances will lead to the formation of new impurities jeopardizing the safety of use of the preparations. They are subject to partial ionization under a given pH. 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.


Pharma recruitment news Education Website. Drug formulated into injectable suspensions because: Pharmacology Notes Education Website.

Fixed oil, such as, arachis oil,cottonseed oil ,almond oil and sesame oil are used as vehicle. Hence,test for pyrogen is done to ensure that water for injection is free from pyrogens.

Raw Materials Used in Parenterals Formulation |authorSTREAM

You do not have the permission to view this presentation. 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.

Plus, get special offers and more delivered to your inbox. 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. WordPress Embed Customize Embed.

However in certain cases, a compromise should be found between the pH ensuring stability of the drug substance such for peptides requiring alkaline pH or proteins at forjulation close to the isoelectric point and the physiological one.

The presentation is successfully added In Your Favorites. Roquette has developed a pyrogen-free range of products with high pharmaceutical standards and paarenterals biocompatible for the manufacture of parenteral preparations, All these pyrogenfree range of products are obtained from natural and renewable raw materials.