Excipients and their use in injectable products - PubMed
Formulation of a new drug product with excipients, that have been previously added to an approved injectable product, may save pharmaceutical companies developmental time and cost. The Physicians' Desk Reference (PDR) and Handbook on Injectable Drugs were reviewed, extracting all information on exci …
Excipients and Their Role in Approved Injectable Products: …
New excipients are being used in early phases of clinical trials to support novel therapeutic entities like RNAi, aptamers, anti-sense, fusion proteins, monoclonal antibodies, and variant scaffolds.
Excipients in Anesthesia Medications : Anesthesia & Analgesia
2018年3月1日 · Excipients in IV anesthesia medications comprise a diverse range of substances that serve many functions. Of 88 drugs included in this analysis, 36 (40%) had one of the 12 excipients that were identified to be associated with adverse events.
A Comprehensive Scientific Survey of Excipients Used in Currently ...
We report the prevalence of each excipient class and excipient chemical used in eight different drug types including monoclonal antibodies, antibody conjugates, cytokines and growth factors, enzymes, polypeptide hormones, pulmonary surfactants, recombinant fusion proteins, and toxins.
Excipients and Their Use in Injectable Products
Formulation of a new drug product with excipients, that have been previously added to an approved injectable product, may save pharmaceutical companies developmental time and cost. The Physicians' Desk Reference (PDR) and Handbook on Injectable Drugs were reviewed, extracting all information on excipients.
Excipients are the integral part of pharmaceutical products development to achieve desired product proile (stability and eficacy). This review deals with understanding of the physicochemical properties of excipients used. in parenteral formulation development for solution, suspension and lyophilized drug products.
FAQs About Excipients - International Pharmaceutical Excipients …
A Type IV DMF is a file within the FDA which can be used by excipient manufacturers to submit confidential formulation, safety and manufacturing information about the excipient that may be needed by the agency in reviewing a new drug application (NDA) for …
Excipient Taxonomy for the 21st Century - Journal of …
These CMAs are properties of the excipients that need to be precisely specified to ensure that the drug product manufacturing process consistently produces a high quality and efficacious medicine. Logically, they are also the excipient characteristics that need to be captured and described by any future approach to excipient taxonomy.
Pharmaceutical excipients — quality, regulatory and …
2016年5月25日 · Practically all medications contain excipients, which are added for the purpose of production enhancement, patient acceptability, improving stability, controlling release etc. Typically excipients are the major components of a drug product, with the active molecule only present in relatively small amounts.
Excipient–Drug Interactions in Parenteral Formulations
2001年12月10日 · These are all examples of positive or synergistic interactions between excipients and drugs. However, excipients may also produce negative effects such as loss of drug solubility, activity, and/or stability. This review article will highlight documented interactions, both synergistic and antagonistic, between excipients and drugs in parenteral ...