IM HealthScience® (IMH®) today announced favorable results from the longest-running post-marketing surveillance study of its type. This study, called Functional Dyspepsia Safety Update at 24 months (FDSU24), is a real-world surveillance study reporting on the safety and tolerability profile of FDgard® (COLM-SST®). Using patented Site-Specific Targeting® (SST®) technology pioneered by IM HealthScience, FDgard is designed to rapidly deliver solid-state, individually triple-coated microspheres of caraway oil and l-Menthol to the duodenum, or upper belly, where they are needed most for the management of Functional Dyspepsia (FD, or recurring, meal-triggered indigestion).
Enforcement Report - Week of May 30, 2018
Enforcement Report - Week of March 1, 2017
Orally Disintegrating Tablets (ODT) have the advantages of both solid dosage form specially the stability and ease of handling and liquid dosage forms including ease of swallowing and pre-gastric absorption. We focused on taste masking and formulation of ranitidine ODT which disintegrates rapidly in the mouth within 60 sec using super-disintegrants, special polymers, water soluble and even insoluble excipients, sweeteners and essence. Various formulations were designed and made in four series. The amount of ranitidine in each formulation was 150 mg, and the final weight of tablets was around 500 mg. Prepared formulations were evaluated in terms of several physicochemical tests including powder/granule flowability, appearance, thickness, uniformity of weight, hardness, friability and disintegration time. Several taste masking techniques were investigated in each series of formulation, in order to cover the bitter taste of ranitidine. These included the addition of sweetener, granulation, solid dispersion with soluble and insoluble agents and complex formation with cellulose derivatives. The best formulation(s) in each group was/were chosen for taste evaluations with the help of 10 volunteers. Finally, formulation F14was selected as the ultimate formulation, based on its better taste and shorter disintegration time (around 5 seconds). Formulation F14contained Na CMC, avicel, Na starch glycolate, xylitol, saccharin, Na benzoate and menthol. The chosen formulation successfully passed the complementary evaluations such as assay of active ingredient and dissolution time. Na CMC was found to be acceptable in terms of decreasing disintegration time and enhanced taste masking potential and can be used in further ODT formulations.
As India's central drug controller sets the ball rolling towards banning the second set of Fixed Dose Combinations, 200 combinations have been spotted by the Central Drug Standards Control Organisation as irrational, as pointed out by senior government officials in the know of the matter. In the latest examination where 300-odd companies were sent letters for around 500 combinations, 200 turned out to be irrational.
BASF halts production at Ludwigshafen plant after deadly explosion
US FDA Enforcement Report- 25/May/2016
A federal appeals court upheld the right of the U.S. Food and Drug Administration to use a report written by an advisory committee that concluded menthol cigarettes pose a greater public health risk than non-menthol cigarettes.nnThe court's ruling overturned an order by District Court Judge Richard Leon's that the report be barred from use.
UK Govt Wants Plain Cigarette Packs by May