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January 24, 2013
Dymista has received medical approval in Europe via the decentralized registration procedure. Dymista is approved for the treatment of seasonal and perennial allergic rhinitis. National registration processes, including negotiations regarding pricing and reimbursement, will now follow in each country prior to launch. Launches are anticipated in 2013 in several countries.
“Patients in Europe that suffer from allergic rhinitis will soon have access to a better treatment option than the current standard therapy. The faster and more complete effect offers significant benefit to the growing numbers of patients suffering from this difficult and inhibiting disease”, said Anders Lönner, CEO of Meda AB.
Dymista is a novel nasal formulation of azelastine and fluticasone. The efficacy and safety of Dymista has been documented in several studies with more than 4,000 patients, including a long-term safety study with more than 600 patients. Dymista has consistently showed faster and more complete symptom relief than standard treatment. Dymista has been available in the US since September 2012.
MEDA AB (publ) is a leading international specialty pharma company. Meda’s products are sold in 120 countries worldwide and the company is represented by its own organizations in 50 countries. The Meda share is listed under Large Cap on the Nasdaq OMX Nordic Stock Exchange in Stockholm. Find out more, visit www.meda.se.
Azelastine is a potent, second-generation, selective, histamine antagonist (histamine-H1-receptor antagonist) manufactured by MedaPharma. According to the Allergic Rhinitis and its Impact on Asthma (ARIA) treatment guidelines, intranasal anti-histamines are recommended for the first line therapy of mild intermittent, moderate/severe intermittent and mild persistent rhinitis (new classification system for rhinitis).
The chemical nomenclature of azelastine is (±)-1-(2H)-phthalazinone, 4-[(4-chlorophenyl) methyl]-2-(hexahydro-1-methyl-1H-azepin-4-yl)-monohydrochloride. It is white, almost odorless with a bitter taste.
Azelastine has been formulated both as a nasal spray (0.1% and 0.15% solutions) and as eye drops (0.05% solution). The nasal spray has been approved in over 60 countries and is marketed under various brand names including Allergodil in mainland Europe, Rhinolast in the UK, Astelin/Astepro in the US, and Azep in Australia. The eye drops have been launched in over 30 countries including the UK (Optilast) and the USA (Optivar). The nasal spray and eye drops are available over the counter in some countries.
Fluticasone propionate, the active component of FLONASE (fluticasone propionate) Nasal Spray, is a synthetic corticosteroid having the chemical name S-(fluoromethyl)6α,9-difluoro-11β-17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17β-carbothioate, 17-propionate and the following chemical structure:
Fluticasone propionate is a white to off-white powder with a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol.
FLONASE (fluticasone propionate) Nasal Spray, 50 mcg is an aqueous suspension of microfine fluticasone propionate for topical administration to the nasal mucosa by means of a metering, atomizing spray pump. FLONASE (fluticasone propionate) Nasal Spray also contains microcrystalline cellulose and carboxymethylcellulose sodium, dextrose, 0.02% w/w benzalkonium chloride, polysorbate 80, and 0.25% w/w phenylethyl alcohol, and has a pH between 5 and 7.