The TRIPS compulsory licensing regime and access to medicines
Olasupo Owoeye in Intellectual Property and Access to Medicines in Africa, 2019
‘Pharmaceutical Product’ is defined in the Decision as any patented product, or product manufactured through a patented process, of the pharmaceutical sector (including active ingredients necessary for its manufacture and diagnostic kits needed for its use) needed to address the public health problems as recognised in Paragraph 1 of the Declaration.123 Only least developed countries and other Members with little or no manufacturing capacities are entitled to take advantage of the system.124 Least developed countries are to be determined in line with UN classification.125 Countries other than the least developed countries are required to prove lack of manufacturing capacity. Proof of insufficient or no manufacturing capacity is either by the Member showing that it has no manufacturing capacity in the pharmaceutical sector or that the Member has no sufficient manufacturing capacity to meet its needs.126 The Implementation Decision does not give a clearer guidance on how countries are to prove the degree of manufacturing capacity they possess. It is thus submitted that an assertion by a country that it lacks a manufacturing capacity should suffice until validly rebutted by any party disputing it. The country exporting under the system is not required to comply with the Article 31(f) requirement of manufacturing predominantly for the supply of domestic market.127 Thus the exporting country can manufacture drugs for export to a foreign market in line with the terms set out in the Decision.
Nonclinical Safety Evaluation of Drugs
Pritam S. Sahota, James A. Popp, Jerry F. Hardisty, Chirukandath Gopinath, Page R. Bouchard in Toxicologic Pathology, 2018
The regulatory authority for pharmaceutical development and marketing approval in the United States is the US Food and Drug Administration (FDA: http://www.fda.gov); in the European Union, the European Medicines Agency (EMA: http://www.ema.europa.eu); and in Japan, the Ministry of Health, Labor, and Welfare (MHLW: http://www.mhlw.go.jp/english). These three regions work together to harmonize the nonclinical safety requirements as part of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The ICH is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. Since its inception in 1990, the ICH has gradually evolved to respond to the increasingly global face of drug development. The ICH’s mission is to achieve greater harmonization worldwide to ensure that safe, effective, and high-quality medicines are developed and registered in the most resource-efficient manner. The reader is encouraged to visit these and other regulatory websites for more detailed information (http://www.ich.org).
Pharmacopeial and Regulatory Guidances on Product Quality and Performance
Anthony J. Hickey, Sandro R.P. da Rocha in Pharmaceutical Inhalation Aerosol Technology, 2019
The FDA is the government agency regulating and enforcing controls on drug products submitted for review and approved for use in the United States. The role of the FDA in reviewing industry data submissions and overseeing the quality of products through on-site inspections gives the agency a high level of scrutiny and the ability to respond quickly to any contingency. In contrast to the USP, the FDA has the opportunity to respond to information on the manufacture and development of the product before it enters commerce. Indeed, it is only after meeting the requirements of the FDA, in part disclosed in guidance documents, that a product will be approved for manufacture, distribution, and sale in the United States. As a consequence, the range of considerations and tests promulgated by the FDA overlaps to some extent with the USP, but often exceeds the USP requirements.
3D printing technology in healthcare: applications, regulatory understanding, IP repository and clinical trial status
Published in Journal of Drug Targeting, 2022
Dipak Kumar Gupta, Mohd Humair Ali, Asad Ali, Pooja Jain, Md. Khalid Anwer, Zeenat Iqbal, Mohd. Aamir Mirza
Drug/pharmaceutical products refer to the finished formulation e.g. tablets, capsules, etc containing the active ingredient and excipients [7]. Conventional drug products like tablets/capsules etc. as not too complex and have a defined shelf life (generally 2yrs). In general, pharmaceutical industries are supposed to be conservative, which avoids deviation from established manufacturing processes and product designs. 3DP breaks these limitations by creating complex and personalised products for rapid consumption [8]. In the era when we are getting exposed to cloud-based computing and contactless payments, the pharmaceutical industries cannot maintain a distance with 3DP for a longer period of time. Technology is now integrating with the pharmaceutical space at a significant pace. Research interests in 3D- printed drug products are also growing immensely which influence the overall drug product development. The major advantage of the technology is that you can get the desired batch size of the product (even for one patient) with tailored dosages, shapes, sizes and release characteristics. Poly-pharmacy (for geriatrics) is the scenario where patients tend to use multiple pills for different health-related conditions. 3D-printed pills can be a single shot solution where they combine different APIs into one formulation. Other than personalised care, it can also deal with emergency situations (disaster areas, military operations, and others) in a much-synchronized way with the demand.
Medicated straw: an innovative drug delivery system for paediatrics
Published in Expert Opinion on Drug Delivery, 2023
Shristhi Sohan Rawat, Arya Rai, Ritu Rathi, Akshay Sharma, Kampanart Huanbutta, Tanikan Sangnim, Inderbir Singh
Taste-masked polymer-coated crystals of paracetamol were loaded into a straw for children and patients with swallowing difficulties [4]. Medicated straws could be loaded with vitamins, minerals, antibiotics, probiotics, and taste-masked medicines for oral administration to enhance patient compliance and potential therapeutic benefits. β-galactosidase enzyme-containing particulates were loaded in polypropylene-based drinking straws. Fluid intake speed and fluid temperature significantly affect the rate of drug release from the medicated straw [5]. Another study developed carvedilol solid dispersion-based electrospun fibers which were loaded into plastic straws. The solid dispersion of carvedilol revealed an ultrafast drug release rate in liquid administration through the straw, as well as enhanced stability, drug dissolution, and better compliance [6]. Generally, active pharmaceutical ingredients are bitter, and sweeteners, flavoring agents, or polymer coatings are employed for enhancing drug palatability.
Pharmaceutical Formulation Methods for Improving Retinal Drug Delivery
Published in Seminars in Ophthalmology, 2019
Tomasz P. Stryjewski, James A. Stefater, Dean Eliott
A familiar memory for anyone having completed a clinical education in medicine is the long hours spent memorizing drugs, dosages, and mechanisms of action for treatment of various ailments. This typical curriculum of clinical pharmacology focuses primarily on the drug’s Active Pharmaceutical Ingredient (also referred to as the drug substance or simply the active ingredient). Less commonly taught is the basis for why various excipients, or inactive ingredients, are included in the final finished form of the drug (also known as the drug product), which allow the drug to act in the manner that is intended. The inclusion of these excipients, which can be included to facilitate manufacturing, improve shelf stability, create an easier delivery method (such as in the form of an oral liquid), or control the kinetics of the drug’s release, can be a “make or break” step in determining whether a drug will cross the chasm from interesting science to a feasible, routinely used clinical therapeutic. The procedure for optimizing the mixture of the drug substance with excipients is known as formulation. This paper reviews the formulation methods used in several commonly used retinal drug products.
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