Formulation considerations for the development of medications with abuse potential
| Autor: | Richard Alexander Moore, Robert S. Mansbach |
|---|---|
| Rok vydání: | 2006 |
| Předmět: |
Drug
medicine.medical_specialty Standardization Substance-Related Disorders Chemistry Pharmaceutical media_common.quotation_subject Biological Availability Pharmaceutical formulation Toxicology Drug Prescriptions Humans Medicine Pharmacology (medical) Dosing Adverse effect Psychiatry media_common Pharmacology Active ingredient Dose-Response Relationship Drug business.industry medicine.disease United States Substance abuse Psychiatry and Mental health Drug development Risk analysis (engineering) Drug and Narcotic Control business |
| Zdroj: | Drug and Alcohol Dependence. 83:S15-S22 |
| ISSN: | 0376-8716 |
| Popis: | The availability of increasingly sophisticated drug formulations and delivery devices has created new opportunities in drug development. These newer approaches can result in improved drug bioavailability, or they can alter key pharmacokinetic parameters in such a way as to decrease dosing interval, decrease variability, or blunt maximal concentrations that are associated with adverse events of particular concern. Special formulations or devices can also provide for easier or more convenient dosing in subpopulations of interest, such as children or the elderly. Although the key principles of abuse potential assessment and the underlying neurochemistry and pharmacology are relatively well understood, evaluation of the influences of drug formulation have received much less study. Because dose and formulation - and even the therapeutic indication - are refined over the course of development, it is usually difficult to conduct more than a cursory evaluation of the influence of formulation on the underlying abuse potential of the active pharmaceutical ingredient. Industrial sponsors would benefit from further research in areas of formulation science and pharmacokinetics that would improve the predictability of prescription drug abuse. In particular, validation of new pharmacokinetic parameters and standardization of methods to understand the consequences of product tampering could assist in gaining a better assessment of risk for controlled release formulations. Such methods could apply not only to innovator products, but also to those wishing to develop generic versions with similar pharmaceutical performance. This article proposes several factors that may be of use to industrial sponsors in making formulation choices for drugs with the potential for abuse. |
| Databáze: | OpenAIRE |
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