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1. (WO2017035619) NASAL PHARMACEUTICAL TESTOSTERONE FORMULATION AND KIT DESIGNED AS A CARD OF UNIT NASAL DEVICES FOR THE APPLICATION OF TESTOSTERONE MONODOSES

Pub. No.:    WO/2017/035619    International Application No.:    PCT/BR2016/050212
Publication Date: Fri Mar 10 00:59:59 CET 2017 International Filing Date: Sat Aug 27 01:59:59 CEST 2016
IPC: A61K 31/568
A61K 9/00
A61J 1/06
A61P 5/26
Applicants: F.B.M. INDÚSTRIA FARMACÊUTICA LTDA
Inventors: DE OLIVEIRA NETO, Moisés Alves
REZENDE, Brandão De Souza
PERILLO, Marcelo Reis
Title: NASAL PHARMACEUTICAL TESTOSTERONE FORMULATION AND KIT DESIGNED AS A CARD OF UNIT NASAL DEVICES FOR THE APPLICATION OF TESTOSTERONE MONODOSES
Abstract:
The invention relates to a nasal pharmaceutical testosterone formulation and of a series of devices that form a packaging card-shaped pharmaceutical kit for nasal administration of testosterone, the kit being formed by a plurality of therapeutically measured single doses or monodoses. The series of devices that form the pharmaceutical kit is characterised by a series of individual devices (1) containing a micronised testosterone gel formulation of high viscosity, with a low hormone dosage, providing to a female or male patient precisely measured and physiologically suitable testosterone unit doses. After use, the device is immediately discarded by the user, without residual hormone losses even during nasal administration, in view of the high viscosity of the formulation which, together with the air pumping device for the medicinal drug contained in the device, ensures the release of practically all the content of the device. Each device comprises a hollow chamber (2) containing the medicinal drug, and an air column zone that acts as a plunger to expel the volume of medicinal drug contained in the chamber (2). The air expulsion chamber (3) provides air compressed by the user inside the hollow chamber (2), which acts as compressed air when it is pressed through the neck (6) located between the hollow chamber (2) and the air chamber (3). Predetermined tearing lines (8 - 9 - 12) make it easier to remove each device from the packaging card before use.