Asuntos regulatorios farmacéuticos: acceso abierto

An accurate, precise, linear, specific and cost effective simple HPLC method has been developed and validated for estimation of Benzalkonium Chloride. Separation of the Preservative was achieved on a L10 column (Dimension: 15 cm × 4.6 mm, 5 μm particle size) using a mobile phase consisting of a mixture of Phosphate buffer (PH 5.5) and acetonitrile (40:60, v/v). The flow rate and detection wavelength were 1 mL/min and 210 nm respectively. The linearity was found in the concentration of 0.05, 0.08, 0.10, 0.12, 0.15, mg/mL as 50% solution of Benzalkonium Chloride with a correlation coefficient (R2) of 0.999. The retention time of Benzalkonium Chloride-1 and Benzalkonium Chloride-2 were 5.965 and 6.993 minutes respectively. The predicted method was validated as per the International Council for Harmonization Guidelines (ICH) for the parameters: Linearity, Accuracy, Precision, Robustness and Specificity. This method can be used for routine analysis of quality control of Benzalkonium Chloride in Ophthalmic dosage form.

This project is developed because patients have modest taste expectations for drug product-they need to be palatable. Palatable drug products generally have moderate attributes – not too bitter, hard, gritty, chalky or irritating. Taste masking of drug by coating of granules preparations of oro-dispersible tablet in-vivo study of taste and in-vitro drug release study is enhance rapid bioavailability and rapid onset of action, improve patient comfort and compliance. Tiemonium methylsulfate prevents the effects of acetylcholine by blocking its binding to muscarinic cholinergic receptors at neuroeffector sites on smooth muscle of GI tract 2 but it is a very bitter drug and slightly soluble in water. So the objective of the present work is to formulate dispersible or orodispersible tablets of this highly bitter drug, where in which its bitter taste is masked. Several techniques are available for the design of taste masking dosage forms as indicated in the introduction chapter. In the present study, the taste masking is done by using ion exchange resin complexation technique. It was preferred over other taste masking methods, as the drug releases occur only in the acidic environment without being released in saliva where by the bitterness of the drug get taste masked. All pre-formulation data compiled the idea property of taste masking oro-dispersible property of tablet. All formulations disintegrate within 60 sec and drug dissolution data showed that all formulation gives around 90% drug release within 120 seconds. Finally we can conclude that this experimental work may be a good way for the development of taste masking and oro-dispersible tablet.

Background: There are many misconceptions about conducting research with Schedule 1 (CI) controlled substances to conduct nonclinical research in the US. Research design cannot be driven by financial constraints.

Aim: The notion that current regulatory control of CI drugs hamper, hinders, or restricts legitimate nonclinical research in the U.S. may reflect a lack of understanding of the procedures in place to study these drugs.

Review: Nonclinical research must comply with the Good Laboratory Practice (GLP) guidelines (21 CFR §58) of the U.S. Food & Drug Administration (FDA). Protocol development under the GLPs provides the information and details required under the Controlled Substances Act (CSA) for submission to the two drug regulating agencies relevant to the approvals required prior to the first dose administration on the study. Under 21 USC § 823(f), the registration applications by practitioners wishing to conduct Schedule I research shall be referred by the Secretary of HHS (FDA), who shall determine the qualifications and competency of each practitioner, as well as the merits of the research protocol. Additionally, a formal verification of the professional standards of the Study Director and the research facility conducting the study will be conducted by the DEA. These additional two requirements differentiate studies conducted with CI drugs and all other schedule-controlled drugs. In the U.S., the security requirements for storage under current DEA administrative regulations are equivalent for both CI and CII drugs.

Conclusion: An informed researcher conducting nonclinical studies with CII– CV drugs can easily comply with current drug control requirements to conduct research with CI drugs in the US.

Obesity is a major public health problem that can affect drug disposition and dosing, particularly in vulnerable pediatric populations. Despite potentially detrimental consequences from inappropriately dosed drugs in children with obesity, drug product labels largely fail to include dosing or guidance specific to this population. Failure to include this information results in an increased incidence of adverse events, and concerns from treating physicians regarding their ability to provide appropriate care for children with obesity. Using data from the National Institute of Child Health and Human Development-funded Pediatric Trials Network (PTN), we explore possible ways to improve drug labeling in children with obesity. In order to improve health outcomes of children with obesity, carefully designed and executed PK trials and comprehensive PK analysis strategies are needed. Early collaboration with the Food and Drug Administration may be helpful in developing studies and analyses that are most beneficial for child health. This collaboration is particularly important for drugs that treat potentially life-threatening diseases, where inclusion of PK and dosing on the drug label is vital. We hope that increasing the body of knowledge on drug dosing in children with obesity will open the door to regulatory guidance based on extrapolation or population-specific PK studies, similar to other currently-recognized special populations. Given the magnitude of the pediatric obesity pandemic, recognition as a special population will offer substantial public health value.

The indigenous medicine involves the use of various plant extracts or the bioactive constituents, phytochemical analysis of such plants confirm the presence of different phytochemicals. Datisca cannabina Linn belong to family Datiscaceae. The whole plant is used in medicines in a mixture forms. The aim of this study was to assess the seeds of Datisca cannabina physicochemically and phytochemically. Maximum bioactive compounds (carbohydrate, alkaloids, proteins and aminoacids, phenolic compounds, flavonoids, glycosides fixed oil and terpenoids) were detected in the extract of methanol, chloroform, acetone and water. Presence of several phytochemical compounds showed high therapeutic potential of Datisca cannabina and it can take for medicinal purposes after determining the seeds pharmacologically.

Medical Device (MD) is one of the fastest growing sectors and so are the associated regulations. From lack of even policies and guidelines to stringent MD legislations in others, the requirements vary across countries. Understanding and interpreting the global MD evolving regulations and requirements is important (for not just the manufacturers, importers, wholesalers and distributors but even the clinicians) in the current global competitive market. This review is an attempt to do that by giving an overview of the prevailing MD regulations in United States (US), Europe and India.

A Nutraceutical product may be defined as a substance, which has physiological benefit or provides protection against chronic disease. The term is applied to products that are isolated from herbal products, dietary supplements, specific diets, and processed foods that other than nutrition are also used as medicine. The major two types are phytochemicals and antioxidants. Emphasis has been made to present herbal nutraceutical seffective on hard curative disorders related to oxidative stress, including Allergy, Alzheimer, Cardiovascular, Cancer, Diabetes, Eye, Immune, Inflammatory and Parkinson’s diseases, as well as obesity. Nutraceuticals provide functional benefits by augmenting the supply of natural building stocks in the body, i.e. it lessens disease symptoms and improves its action. A healthy life, self-confidence, improved working capacity can be achieved on the proper administration of nutraceuticals. Therefore, if research continues it may help future researchers in identifying a right plant molecule to treat different diseases or to develop food formulations for better management. The rational awareness “from treatment to prevention” leads the increase in demanding the nutraceuticals.

The improvement of a medication from an underlying plan to its entrance into the market is an extreme process which can take around 8-12 years and cost around $1.7 billion. The thought for another advancement can originate from an assortment of sources which incorporate the flow necessities of the market, new rising infections, good clinical research, business part, and so on. Once an objective for revelation has been picked, the pharmaceutical businesses or the related scholastic focuses take a shot at the early procedures to recognize the substance atoms with reasonable qualities to make the focused on medications. This article will provide information on the key ideas of drug discovery, drug development and clinical phases of the drug discovery.