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Excipients for Parenteral Use
Published in Sandeep Nema, John D. Ludwig, Parenteral Medications, 2019
Sandeep Nema, Ronald J. Brendel
A typical definition of parenteral is not oral or not through the alimentary canal. As defined in the European Pharmacopeia and the British Pharmacopeia, “Parenteral preparations are sterile preparations intended for administration by injection, infusion, or implantation into the human or animal body.” However, for the purposes of this chapter, only sterile preparations for administration by injection or infusion into the human body will be surveyed.5,6 Injectable formulations are subject to a strict set of requirements. The formulated product has to be sterile, pyrogen free, and in the case of solution, essentially free of visible particulate matter. Coloring agents added solely for the purpose of coloring the parenteral preparation are not allowed. An isotonic formulation is preferred, and depending on the route of administration, some excipients may be prohibited. Certain drugs administered by injection, rather than orally, may pose a higher risk for an adverse event or the drug’s effect may be especially difficult to reverse because the injected drug bypasses natural defense barriers and is quickly distributed throughout the body. The excipient must be able to withstand the rigors of the sterilization process such as the very high temperatures required for terminal steam sterilization or filtration and lyophilization in aseptic processing. All of the above factors can limit the choice of excipients available to the formulator.
Parenteral Drug Delivery Systems
Published in Ambikanandan Misra, Aliasgar Shahiwala, In-Vitro and In-Vivo Tools in Drug Delivery Research for Optimum Clinical Outcomes, 2018
Aliasgar Shahiwala, Tejal A. Mehta, Munira M. Momin
Parenteral drug delivery is the most effective delivery for the drugs, as it has a narrow therapeutic index and is unstable in the gastrointestinal tract when administered orally. Also, there is a huge demand of protein- and biotechnology-based drugs in the treatment of certain diseases like cancer and viral diseases. These products are unstable when given orally and thus show poor bioavailability. However, conventional parenteral products have their own limitations in terms of specific targeting and delayed release. This leads to lots of research in novel parenteral drug delivery which is devoid of these side effects. Since last two decades, research in parenteral route of administration is increasingly been pursued. Even though extensive efforts were made for the systemic application of the drugs through alternative routes of administration, which includes mainly the nasal, buccal, pulmonary, and transdermal routes, poor and high variability in systemic absorption is still a major challenging issue. Major parenteral routes for drug administration are subcutaneous (s.c.), intramuscular (i.m.), and intravenous (i.v.). The intradermal and intra-arterial routes are used for specific purposes only.
Environmental Standards, Manufacturing Operations,and Good Manufacturing Practice
Published in Thomas A. Barber, Control of Particulate Matter Contamination in Healthcare Manufacturing, 1999
Pharmaceutical/biopharmaceutical clean-room requirements depend on manufacturing procedures and on the final use of the manufactured products. For example, the manufacturing requirements for an oral drug are not the same as those for a parenteral drug. Oral drugs are ingested, and by the time they get into the bloodstream, many body defense mechanisms have been activated (starting with saliva). It is most likely that viable organisms present in the ingested product will be destroyed. When a parenteral drug is injected into the bloodstream, the administration route bypasses the body's natural defenses. A parenteral product must, therefore, be free of viable organisms that are capable of multiplying to cause an infection (i.e., sterile). This is why cleanrooms used in oral drug pharmaceutical plants may in some cases be Class 100,000, while cleanroom classifications for parenteral products are more stringent, ranging from Class 100 to Class 10,000. Biopharmaceutical drugs are mostly injectable drugs for which special processes are employed to prepare and/or alter biological molecules in product destined to become diagnostic or therapeutic.
Significant biopolymers and their applications in buccal mediated drug delivery
Published in Journal of Biomaterials Science, Polymer Edition, 2021
Introduction of medical therapy into the patient body invasively through different routes other than the oral route is known as the parenteral route. It includes intramuscular (IM), intravenous (IV), intra-arterial (IA), and subcutaneous (SC) routes. This route has a very important role in the medical field as many drugs can only be administered by this route. The drug delivered by the traditional parenteral route (IV or IM) directly enters the systematic veins, by eliminating the first-pass metabolism and ultimately distributed to the whole body including the brain through the vascular system [3]. A unique advantage of this system is dense brain capillary which tends to deliver therapeutic agents to surrounding blood cells which makes it beneficial in case of treatment of central nervous system (CNS) diseases. This route allows the instantaneous delivery of drugs. This route allows the potential amount of drug delivery directly to the blood capillaries which allows rapid absorption of the drug.