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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So, buffers are used to adjust and maintain pH in order to increase stability, solubility, absorption and activity of API.

Raw Materials Used in Parenterals Formulation |authorSTREAM

While selecting the additives ,care must be taken that they should be compatible both physical and chemical with the entire formulation. The main challenge of all the different parenteral dosage forms is to achieve a good compatibility of the drug parenteralz with the excipients no formation of new impurities either by degradation of the drug substance or formation of new chemical entity od the drug substance and the parentegals as well as the compatibility of the preparations with the primary container no leachable or adsorption to container.

Parenteral preparations are sterile and pyrogen-free preparations intended to be administered directly into the systemic circulation in human or animal body.

Used to prevent degradation and denaturation of injectable protein formulations such as insulin. They are added to protect components of the dosage form, which are subject to chemical degradation by oxidation.

Parenteral Preparations, Challenges in Formulations

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. Metal ions enhance the oxidation process ,hence these are to be turned off by chelating agents PowerPoint Presentation: Used to protect drug against loss of activity caused by stress that is introduced by manufacturing process.


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.

In all cases, large volume preparations LVP, i. Study material for Pharma students updated their status. Emulsifying agents are used in sterile emulsions. The pH is one of the critical aspects of parenteral preparations which should have a pH close to the physiological one. Pharmacology Notes Education Website.

In thisparent drug is modified. These adjuvants should be used only when it is absolutely necessary to use them. These are contrast media having radioactive iodine, chromium, technetium, iron etc meant for evaluation of organ functions.

The stability of the drug substance is another critical point that a formulator can face during the development of the formulation. I am a Pharmacist.

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. As most drugs are weak acids and bases. 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.


Unstable drug substances will lead to the formation of new impurities jeopardizing the safety of use of the preparations. You do not have the permission to view this presentation. See more of Study material for Pharma students on Facebook.

Formulation of parenteral preparations the formulation of parenteral preparations need careful planning ,thorough knowledge of medicaments and adjuvants to be used. 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 pH close to the isoelectric point and the physiological one. 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.

The stabilizers are added in the formulation to prevent this. Sections of this page.

Therefore it is not used commonly. When these are used as vehicles,then formulations should not be diluted with water as precipitation may occur. Fixed vegetable oils are used Prolong drug release at site of administration can be achieved when converted to oily suspension.

F suspending ,emulsifying and wetting agents: Drug formulated into injectable suspensions because:

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