China
Africa
Explore chapters and articles related to this topic
Fenugreek Based Products in USA, Australia, Canada, and India
Published in Dilip Ghosh, Prasad Thakurdesai, Fenugreek, 2022
Savita Nimse, Sanjeevani Deshkar
The TGA provides access to information about ingredients that are permissible to be used in the products. The TGA Business Services website has a searchable database of approved terminology for chemical, biological, and herbal ingredients, including the active ingredients, excipients, and components and equivalents of ingredients that may be used in TGA-regulated therapeutic goods. This database for ingredients is called the “Ingredients table”. There are two types of ingredients, active and excipients. An active ingredient is the therapeutically active component in a medicine’s final formulation that is responsible for its physiological action. An excipient ingredient is any component of a finished dosage form, other than an active ingredient. The ingredient searched in the ingredient table gives the “Ingredient summary” which provides the approved role of the ingredient (active or excipient). Fenugreek (the ingredient ID 59791) is summarized for use as “an active ingredient” in categories such as Export Only, Listed Medicines, Over the Counter, or Prescription Medicines. It is also available for use as a “Homoeopathic Ingredient” in “Listed Medicines” and for use as an “Excipient Ingredient” in categories of Export Only, Listed Medicines, Over the Counter, or Prescription Medicines.
Drug Substance and Excipient Characterization
Published in Dilip M. Parikh, Handbook of Pharmaceutical Granulation Technology, 2021
Parind M. Desai, Lai Wah Chan, Paul Wan Sia Heng
Although excipients have traditionally been thought of as being inert, experience has shown that they can interact with a drug. Readers are encouraged to refer to the literature on drug–excipient interactions and their effects on drug absorption [93]. Incompatibility may occur between drug and excipient, as well as between the excipients themselves, and affect the potency, stability, and eventually, therapeutic efficacy of the product. It is therefore essential to avoid incompatibility and this can be achieved by carrying out studies to detect potential chemical interactions between the different components used in the formulation.
The administration of medicines to children
Published in Evelyne Jacqz-Aigrain, Imti Choonara, Paediatric Clinical Pharmacology, 2021
Evelyne Jacqz-Aigrain, Imti Choonara
To produce drug preparations appropriate for different routes of administration and to ensure their acceptability and long term stability requires the addition of certain other chemicals or substances called excipients. Excipients should be pharmacologically inactive but many have some effect and can produce adverse reactions in some patients. Those that are absorbed from the gut, skin and mucus membranes or injected, may have systemic effects and may be metabolised and eliminated by the liver and kidney. Developmental pharmacology may be as important for the handling of some excipients as it is for ‘active’ substances. Drug regulatory agencies determine which excipients are acceptable and they usually set exposure limits and labelling requirements for the finished product [1].
A systematic review of commercial high concentration antibody drug products approved in the US: formulation composition, dosage form design and primary packaging considerations
Published in mAbs, 2023
Indrajit Ghosh, Hiten Gutka, Mary E. Krause, Ryan Clemens, Ramesh S. Kashi
There is a tremendous urgency and need for the development and commercialization of mAb products that exceed >200 mg/mL, especially in treating immune-related disorders that require higher doses (>30–50 mg/kg) delivered by SC administration. To achieve higher mAb concentration, high solution viscosity poses a major technical hurdle that needs to be overcome. Substantial research and development efforts are ongoing in both academia and industry to identify and develop novel excipients and FDA-approved excipient combinations to reduce the viscosity of high concentration mAb products. The use and approval of novel excipients in biologics formulations has been slow, but the FDA’s Center for Drug Evaluation and Research has recently launched the voluntary Novel Excipient Review Pilot Program, which is intended to allow excipient manufacturers to obtain FDA review of certain novel excipients prior to their use in drug formulations
Strategies for the drug discovery and development of taxane anticancer therapeutics
Published in Expert Opinion on Drug Discovery, 2022
Changwei Wang, Angelo Aguilar, Iwao Ojima
Several issues with the taxanes already in clinic have been identified. One of these is the use of excipients which is required to overcome their very poor aqueous solubility [9]. There have been some cases in which the use of these excipients have led to serious side effects. Once this happens, the patients must be removed from the treatment immediately [9]. The second problem is multidrug resistance [10,11]. There are quite a few major mechanisms for multidrug resistance (MDR): (1) Overexpression of efflux pumps, especially P-glycoprotein (Pgp) and multidrug resistance-associated proteins 1 (MRP1); (2) Decrease in the cellular uptake of drug by overexpression of plastin-3, decrease of organic anion transporting polypeptide 1B3, and changing membrane compositions mostly via increasing cholesterol percentage; (3) Changing apoptotic pathways by overexpression of Bcl-2 protein that strongly binds to paclitaxel; (4) Point mutation of tubulin, particularly the expression of βIII isoform in β-tubulin; 5) Widely existing hypoxic microenvironment in solid tumors; and 6) Metabolism-based resistance [9,11,12].
An expert opinion on respiratory delivery of high dose powders for lung infections
Published in Expert Opinion on Drug Delivery, 2022
Bishal Raj Adhikari, Jack Dummer, Keith C. Gordon, Shyamal C. Das
A number of excipients have been investigated with the aim of optimizing the aerosol performance of dry powder. While using excipient in the formulation, the research can concentrate on how to minimize the concentration of the excipient while maximizing aerosolization. Furthermore, a lot of these excipients are not currently FDA-approved. Research focused on assessing the safety of potential new excipients could therefore ameliorate problems associated with product development. Appropriate selection of drug-excipient combination or prodrugs that can selectively target the pathogen can ensure higher concentration of drugs reaching the target pathogen. Further, use of nanoparticles such as liposomes and polymeric particles (sections 2.2 and 5.3.2) can be used to improve drug lung residence time or biofilm penetration for better therapeutic efficacy with inhaled therapy. Converting these nanoparticles to nanocomposites to reduce exhalation is a smart formulation technique. Nevertheless, the low drug loading capacity of these nanoparticles might be of concern even if they were loaded into microparticles for inhalation.