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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Roquette has developed a pyrogen-free range of products with high pharmaceutical standards and being biocompatible for the manufacture of parenteral preparations, All these pyrogenfree range of products are obtained from natural and renewable raw materials.

It is the ability of a solid material to exist in more than one form or crystal structure. 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.

Includes drugs in solution, suspension, gel or ointment meant for administration in to the corneal surface of the eye. Finally the process of the sterilization 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 wetting agents are used to reduce the interfacial tension between the solid particles and the liquid, so as to prevent the formulation of lumps. These are sub visible particles. As formulaation drugs are weak acids and bases. Emulsifying agents are used in sterile emulsions. The main challenge of all the different parenteral dosage forms is to achieve a good compatibility fomrulation 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.


Parenteral Preparations, Challenges in Formulations. These adjuvants should be used only when it is absolutely necessary to use them. Mineral oils cannot be used as they are not absorbed by body tissues.

Therefore it is not used commonly. Sunday, November 20, The stabilizers are added in the formulation to prevent this.

Parenteral Preparations, Challenges in Formulations

Pqrenterals can be classified as: In order to decrease drug solubility for improving its stabilitywe can: F suspending ,emulsifying and wetting agents: Ethyl alcohol is used in the preparation of hydrocortisone injection. When drug substances 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.

While selecting the additives ,care must be taken that they should be compatible both physical and chemical with the entire formulation. The excess use of adjuvants in parenteral products should be avoided pparenterals some of these may interfere with the drug.

See more of Study material for Pharma students on Facebook. 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. Fixed oil, such as, arachis oil,cottonseed oil ,almond oil and sesame oil are used as vehicle.

  ASTM E1256 PDF

Raw Materials Used in Parenterals Formulation |authorSTREAM

Antioxidants prevent or inhibit oxidation of drug. 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. So, buffers formulatino used to adjust and maintain pH in order to increase stability, solubility, absorption and activity of API. In all cases, large volume preparations LVP, i.

Plus, get special offers and more delivered to your inbox. Metal ions enhance the oxidation process ,hence these are to be parenterale off by chelating agents.

Sections of this page. The aqueous ofrmulation used are ;- 1 water for injections. 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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In thisparent drug is modified.