Enforcement Report - Week of November 7, 2018
Maia Pharms Generic Sodium Benzoate; Sodium Phenylacetate Receives Approval In US
Swedish Orphan Biovitrum AB (publ) (Sobi™) today announces that the company has entered into a 3-year agreement with Valeant Pharmaceuticals Ireland for the distribution of Ammonul® (sodium phenyl acetate and sodium benzoate) injection in Europe, the Middle East and North Africa. The new agreement replaces the current distribution agreement with Valeant Pharmaceuticals North America LLC for the same territory. Under the new agreement, Sobi will have exclusive rights and license for sales and distribution of Ammonul in Europe, the Middle East and North Africa until 31 December 2019 for named patient use (NPU) programmes.
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.
A new analysis unveiled by the industry’s two biggest lobbies–the American Hospital Association and the Federation of American Hospitals–is the latest salvo in an escalating battle in Washington over prescription drug costs. Lately, drug makers like Mylan MYL -3.38% deflect price hikes for the EpiPen on pharmacy benefit managers while PBMs and insurers point fingers at the pharmaceutical industry. Hospitals are now entering the fray, with a University of Chicago analysis showing large price increases in just a short time on medicines that have generally been around for years, such as drugs used during surgery or anesthesia.
Navinta' Generic Sodium Phenylacetate And Sodium Benzoate Approved In US
Ailex Pharm`s Generic Sodium Phenylacetate And Sodium Benzoate approved in US for the treatment of hyperammonemia
The STEP stands for Safety and Toxicity of Excipients for Paediatrics. The STEP database is a user-designed free resource that compiles the safety and toxicity information of excipients that is manually extracted from selected information sources. Three tier quality control procedures are implemented from information retrieval level to entry of the specific data in the database.
Brenton Saunders, the whiz-kid pharmaceutical executive with a reputation for being wary of the costs of early-stage drug development, says he's open to new ideas from outside and is now warming up to investing in drug discovery if it makes sense for his company.