Comparison of WHO and US FDA biowaiver dissolution test conditions using bioequivalent doxycycline hyclate drug products

Simvastatin is commercially available as tablets and compounded capsules in Brazil. Very few reports regarding these capsules' quality, and consequently their efficacy, are available. The pharmaceutical quality of 30 batches of 20 mg simvastatin capsules from the market was evaluated by weight determination, content uniformity, disintegration (Brazilian Pharmacopeia), assay and dissolution test (USP32 tablet monograph). A HPLC method was developed for assay, content uniformity and dissolution test, and specifications were also established. Out of the 30 batches evaluated, 29 showed capsule disintegration within 45 min and individual weight variation was within ±10% or ±7.5% relative to average weight, for < or > 300 mg, respectively. Only 27 batches met dissolution test criteria with values >80% of the labeled amount in 45 min; 21 batches showed simvastatin content between 90.0-110.0% of the labeled amount and 19 batches had at least 9 out of 10 capsules with content uniformity values between 85.0-115.0% of the labeled amount with RSD<6.0%. Only 14 of all (30) batches fully met pharmacopeial quality standards. The establishment of test conditions and specification parameters for simvastatin capsules showed that there are relevant pharmacopeial quality differences between batches compounded by different pharmacies. For 53.33% of the tested products hypercholesterolemic treatment efficacy may be compromised.

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An audit of drug package insert: a survey based study in India

International Journal of Basic & Clinical Pharmacology ◽

10.18203/2319-2003.ijbcp20170826 ◽

2017 ◽

Vol 6 (3) ◽

pp. 629

Author(s):

Priyanka P. Hotha ◽

Purvi J. Tanna

Keyword(s):

Package Insert ◽

Primary Source ◽

Healthcare Services ◽

Medical Product ◽

European Medicines Agency ◽

Drug Label ◽

Package Inserts ◽

Drug Products ◽

United States Food ◽

Us Fda

Background: The primary source of drug information is a Package Insert. It is a printed leaflet that contains information based on regulatory guidelines for the safe and effective use of a drug. It is also known as prescription drug label or prescribing information. Regulatory requirements for drug package inserts or leaflets vary across nations. United States-Food and Drug Administration (US-FDA) and European Medicines Agency (EMA) amend their regulations governing the content and format of labelling for drug products from time to time. US-FDA has published a revised guideline in the Federal Register of January 2006, which is being followed by pharmaceutical industry of the country.Methods: Around 192 package inserts were collected from pharmacies located at different areas. They were analyzed according to Sections 6.2 and 6.3 of Schedule D of Drugs and Cosmetics Rules, 1945.Results: Out of 192 package inserts, most available information in therapeutic indications is Posology and method of administration (97.3%) followed by Contra-indications(93.2%) in pharmaceutical information, it is Special precautions for storage (77%) followed by Shelf life in the medical product as packaged for sale (33.8%).Conclusions: Contents of the package inserts should be complete, reliable and up to date. This can be a step forward for ethical and effective dissemination of healthcare services in our growing society. Therefore, recommended to update the existing package inserts based on criteria mentioned in the Schedule D of Drug and Cosmetic Act, 1945.

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Design of Experiments for the Establishment of the Dissolution Test Conditions of Rupatadine Fumarate 10 mg tablets

Journal of Drug Delivery and Therapeutics ◽

10.22270/jddt.v9i1-s.2359 ◽

2019 ◽

Vol 9 (1-s) ◽

pp. 331-336 ◽

Cited By ~ 2

Author(s):

Castillo Henríquez Luis ◽

Madrigal Redondo German ◽

Vargas Zúñiga Rolando ◽

Carazo Berrocal Gustavo

Keyword(s):

Design Of Experiments ◽

Statistical Model ◽

Rotation Speed ◽

Dissolution Test ◽

Dissolution Medium ◽

Independent Variables ◽

Test Conditions ◽

Pharmaceutical Technology ◽

Dependent Variables ◽

Pharmaceutical Form

Design of Experiments (DoE) is a statistical model that aims to determine if the factors under study affect the response, and if so, it determines the conditions under which this variable of interest can be optimized. In terms of pharmaceutical technology, independent variables are usually factors of the formulation, while dependent variables are properties of the product or parameters that indicate the performance of the process. Precisely, the dissolution test is a tool of interest for the developers of medicines since it allows them to evaluate the performance of a formulation designed in a solid pharmaceutical form, such as tablets. The present investigation used the design of experiments to establish and optimize the conditions of the dissolution test of a 10 mg Rupatadine fumarate tablets formulation, resulting in the use of HCl 0,1 N (pH 1) dissolution medium and a rotation speed of 100 rpm for the apparatus II USP, which allow the analysis of the product in a reproducible and reliable way. Keywords: Analysis of variances, Design of experiments, Dissolution test, Factorial design, Rupatadine Fumarate, Tablets, Test conditions.

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The Scope and Challenges of Vesicular Carrier-Mediated Delivery of Docetaxel for the Management of Cancer

Current Drug Delivery ◽

10.2174/1567201817666200623121633 ◽

2020 ◽

Vol 17 (10) ◽

pp. 874-884

Author(s):

Charu Misra ◽

Kaisar Raza ◽

Amit Kumar Goyal

Keyword(s):

The United States ◽

Drug Products ◽

Cancer Management ◽

Vesicular Carriers ◽

The Us ◽

United States Food ◽

Potential Benefits ◽

States Food ◽

Us Fda ◽

Novel Drug

Since the discovery of liposomes, these vesicular carriers have attracted the researchers from all the vistas of the biomedical domain to explore and harness the potential benefits. Many novel drug delivery-based products have been approved by the United States Food and Drug Administration (USFDA) and other federal agencies of the globe, out of which the major share is of the liposomes and related carriers. Taking cognizance of it, the US-FDA has recently come up with ‘Guidance for Industry on Liposome Drug Products’. In cancer management, chemotherapy is the most frequently employed approach which is still not devoid of untoward challenges and side effects. In chemotherapy, the taxanes, esp. Docetaxel shares a huge percentage in the prescription pattern. Also, the first marketed liposomal product was encasing one drug of this category. Henceforth, the present review will highlight the advances in the delivery of taxanes, in particular docetaxel, with an emphasis on the need, success and pharmacoeconomic aspects of such vesicular-carrier mediated docetaxel delivery.

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