Essential Steps: Products shall be released only after complete filling and testing. Result of the tests relating to sterility, pyrogens, and Bacterial endotoxins shall be maintained in the analytical records. Validation details and simulation trail records shall be maintained separately, Records of environmental monitoring like temperature, humidity, microbilogical data, etc. Records of periodic servicing of HEPA filters, sterilizers and other periodic maintenance of facilities and equipment carried out also be maintained.
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Like any pharmaceutical dosage forms, they are required to meet the pharmaceutical quality standards as described in pharmacopeias and to be safe for the intended purpose of use. They are usually supplied in single dose glass or plastic containers. PVC is nowadays less recommended. More and more they are being supplied in pre-filled syringes or pens to facilitate ease of use. Properties of parenteral preparations Parenteral preparations are intended to be administrated through the human or animal body, either by direct injections, for example, bolus intravenous IV , intramuscular IM or subcutaneous SC , or by infusion with a controlled infusion rate or by direct implantation through IM or SC.
They must meet the following minimum compendia criteria1,2,3: To be sterile and pyrogen-free; To be clear or practically exempt of visible particle and to be free from sub-visible particles as required by pharmacopeias EP, USP and JP; No evidence of phase separation for the emulsions, or aggregates formation for aqueous dispersion such injectable Mab monoclonal antibody preparations; and In the case of suspensions, the use of appropriate particle size and any sediment should be readily dispersed upon shaking to give stable formulations and ensure the correct dose to be withdrawn and injected.
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. It should be stressed that excipients should not adversely affect the intended medicinal action of the drug products, nor at the concentration used to cause toxicity or undue local irritation. Challenges in formulations The main challenge of all the different parenteral dosage forms is to achieve a good compatibility of 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.
When drug substances are not soluble, dissolution can be achieved with the use for instance of either co-solvents, surfactants, a soluble pro-drug, or eventually the use of solubility enhancers such the cyclodextrins due to the formation of inclusion complex.
The pH is one of the critical aspects of parenteral preparations, which should have a pH close to the physiological one. However, in certain cases, a compromise should be found between the pH ensuring stability of the drug substance, such as for peptides requiring alkaline pH or proteins at pH close to the isoelectric point, and the physiological one.
In all cases, large volumes preparations—LVP, i.
Parenteral Preparations: Challenges in Formulations
Formulation design and development of parenteral suspensions.