The TNX-102 SL sublingual formulation is based on a eutectic between cyclobenzaprine HCl and mannitol, which protects the acidic hydrochloride salt of cyclobenzaprine from molecular interactions with the basic excipient, potassium phosphate dibasic, which is added to enhance transmucosal absorption.
The Protectic protective eutectic and Angstro-Technology formulation enable TNX-102 SL to be a sublingual tablet of cyclobenzaprine HCl, while ensuring that the tablets have robust manufacturability and pharmaceutical stability.
67 Cyclobenzaprine HCl
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Tonix Pharmaceuticals, a specialty pharmaceutical product development and commercialisation company, has received approval from the US Food and Drug Administration for its Investigational New Drug application to develop TNX-102 SL, a proprietary sublingual formulation of cyclobenzaprine HCl
, it was reported yesterday.
Mylan said it was the first company to have filed a substantially complete ANDA containing a Paragraph IV certification for Cyclobenzaprine HCl ER Capsules and that it was awarded 180 days of marketing exclusivity.
Cyclobenzaprine HCl ER Capsules are the generic version of Cephalon's (NASDAQ: CEPH) Amrix Capsules, a muscle relaxant.
Tenders are invited for Supply of cyclobenzaprine hcl
The company was the first to have filed a substantially complete ANDA containing a Paragraph IV certification for Cyclobenzaprine HCl
ER Capsules and was awarded 180 days of marketing exclusivity.