Pharmaseutical development of polyion solutios for infusions. justification of presence of active pharmeceutical ingridients and additions
Modern manufacturing of any pharmaceutical treatment is impossible without a precise scrutiny of all factors that may influence on quality of end-product. As well quality has to be taken into account while developing this product.
According to regulatory documentation the following key points should be taken into account while developing pharmaceutical product: all compounds (active and additions) and their compatibility, physicochemical characteristics all ingredients of this product, form of administration and its physicochemical characteristics, compatibility with another pharmaceutical products, packaging materials,workflow details, type and mode of sterilization and many other details depending on specific pharmaceutical product release.
Objective. Justification polyionic composition of infusion solutions containing cations: sodium, potassium, calcium, magnesium; anions: chlorides, acetates, lactates, hydrocarbonate ions, as well as glucose.
Used Pharmacopoeia, regulatory guidance, references and their own research using bibliosemanticheskih and empirical methods.
A big quantity of components in compound of infusions is a specific feature of any polyelectrolyte solutions. Usually, cations and anions which are in compatibility with electrolyte compound of plasma applied for electrolyte infusions. In this list: cations of sodium, potassium, calcium, magnesium, anions of chlorides, acetates, lactates, hydrocarbonate ions and glucose.
Choice and concentration of buffering agent should be justified as well. Solutions for infusions are aqueous solutions which have important physicochemical features in their compound, such as stability and aqueous solubility. Along with hydrophilic characters they should have lipophilic characteristics for penetration through biological membranes of vessels.
Solutions for infusions consist of big amount of ingredients. Therefore, their compatibility with each other has to be proved.
For manufacturing of solution for infusions additions which are used should meet the following criteria: provide isotonicity of pharmaceutical product in reference to blood plasma, control pH, improve solubility of active ingredients, prevent decompounding during manufacturing and storage. Physicochemical features of active ingredients such as tendency of ingredients to hydrolysis, oxidation, decompounding during thermal sterilization should be taken into account while selection of additions for solution for infusions
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