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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To make the formulation isotonic. Used to protect drug against loss of activity caused by stress that is introduced by manufacturing process. As most drugs are weak acids and bases. While selecting the additives ,care must be taken that they should be compatible both physical and chemical with the entire formulation.

When drug substances are not soluble, dissolution can be achieved by the use of formullation, surfactants, or a soluble pro-drug, or eventually the use of solubility enhancers such as cyclodextrins thanks to the formation of inclusion complex.

Alcohol causes pain and tissue damage at the site of injection. They must meet the following minimum com-pendia criteria: Metal ions enhance the oxidation process ,hence these are to be turned off by chelating agents.

Raw Materials Used in Parenterals Formulation |authorSTREAM

Study material for Pharma students updated their status. These are contrast media having radioactive iodine, chromium, technetium, iron etc meant for evaluation of organ functions. In all cases, large volume preparations LVP, i. Chelating agents are compounds that can form complexes with metal ions, and in so doing inactivate the catalytic activity parentfrals the metal ions in the oxidation process.


It is done because osmotic pressure changes and resultant exchange of ionic species across RBC membrane causes many problems. So, buffers are used to adjust and maintain pH in order to increase stability, solubility, absorption and activity of API. The wetting agents dormulation used to reduce the interfacial tension between the solid particles and formulatoon liquid, so as to prevent the formulation of lumps. When these are used as vehicles,then formulations should not be diluted with water as precipitation may occur.

It prevents loss of API from adsorption on process equipment.

Parenteral Preparations, Challenges in Formulations. Antioxidants prevent or inhibit oxidation of drug.

Parenteral Preparations, Challenges in Formulations

Formulation of parenteral preparations the formulation of parenteral preparations need careful planning ,thorough knowledge of medicaments and adjuvants to be used. The stability of the drug substance is another critical point that a formulator can face during the development of the formulation.

Modification of the drug may occur inside the body or during the reconstitution of the injection. Fixed vegetable oils are used Prolong drug release at site of administration can be achieved when converted to oily suspension. Sections of this page. Therefore it is not used commonly. Metal ions enhance the oxidation process ,hence these are to be turned off by chelating agents PowerPoint Presentation: The stabilizers are added in the formulation to prevent this.

Import from China Business Service. 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.

I am a Pharmacist. 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. They should meet the pharmaceutical quality standards as described praenterals pharmacopeias and ICH guidelines and also ensure the clinical tolerance as well as to be safe for the intended purpose of use.


It should be stressed that excipients should not adversely affect the intended formulatiin action of the drug products, nor at the concentration used to cause toxicity or undue local irritation. Chemistry Masala Personal Blog. Prepared by following methods: 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.

Fixed oil, such as, arachis oil,cottonseed oil ,almond oil and sesame oil are used as vehicle.

To disperse a frmulation 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. These are sub visible particles. They are subject to partial ionization under a given pH. See more of Study material for Pharma students on Facebook. Plus, get special offers and more delivered to your pxrenterals.

It is the ability of a solid material to exist in more than one form or crystal structure. Modified by preparing estersalt or some other derivative in order to: