The aseptically prepared large volume parenteral containing important necessary nutritional components for beneficial effect such as vitamins, glucose, amino acids, fats, etc. with pharmaceutical active drug is called parenteral admixture. It is manufactured directly by pharmaceutical companies after exhaust analysis of potential chemical or pharmaceutical interactions within the admixture and drugs. Before that nurses and physicians manufacture the admixtures in the hospital for the particular patient during their hospitalization using individually packed sterile components to maintain aseptic condition. The purpose of parenteral admixture is to enhance the therapeutic effectiveness as well as the stability of the product, reduce the side effect of the drug, and maintain the nutritional and electrolyte balance in the body. Parenteral admixture-utilizing countries regulate the manufacturing practice to assure the quality, stability, and microbiological integrity of the parenteral admixture. In the chapter, brief discussion of additives, their application, manufacturing, and regulatory aspects has been explored.

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Sterile Products and Admixtures

  • Satish Shilpi,
  • Amit K. Dubey,
  • Shalini Bajaj,
  • Shashank Shekar Mishra,
  • Chetan Ram,
  • Debasis Gantayat,
  • Vibhooti Pippola,
  • Khyati Saini

摘要

The aseptically prepared large volume parenteral containing important necessary nutritional components for beneficial effect such as vitamins, glucose, amino acids, fats, etc. with pharmaceutical active drug is called parenteral admixture. It is manufactured directly by pharmaceutical companies after exhaust analysis of potential chemical or pharmaceutical interactions within the admixture and drugs. Before that nurses and physicians manufacture the admixtures in the hospital for the particular patient during their hospitalization using individually packed sterile components to maintain aseptic condition. The purpose of parenteral admixture is to enhance the therapeutic effectiveness as well as the stability of the product, reduce the side effect of the drug, and maintain the nutritional and electrolyte balance in the body. Parenteral admixture-utilizing countries regulate the manufacturing practice to assure the quality, stability, and microbiological integrity of the parenteral admixture. In the chapter, brief discussion of additives, their application, manufacturing, and regulatory aspects has been explored.