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nitropatch
INTRODUCTION

Brunifarma is the first to introduce the nitroglycerin band aid onto the European generic drugs market, following years of pharmaceutical and pharmacological research and development at sites approved by European Authorities and the American national regulatory body, FDA. The applicable technology for the Nitro-patch is formed by:

Drug-in-Adhesive matrix band aid

Nitropatch

The main feature of this type of band aid is the presence of the active ingredient directly in the adhesive in contact with the skin. The adhesive layer performs a dual function of attaching the product to the skin and containing and releasing the active ingredient. The three-dimensional matrix regulates the speed at which the active ingredient is transferred in a consistent manner: respectively 0.2 mg, 0.4 mg and 0.6 mg per hour for the three different dosages available (5 mg, 10 mg, 15 mg). The nitroglycerin released by the band aid has proven to be well absorbed and can in fact be detected in the plasma 30 minutes after its application, with maximum concentration reached after approximately two hours. Plasma concentration is constant over the 24 hour period and is always in proportion to the dose.

ACTIVE INGREDIENT

Nitroglycerin is used for the prophylaxis and treatment of angina pectoris both under strain and at rest, whether associated with or consequent to coronary insufficiency, insofar as it provokes as a direct effect, the vasodilation of veins and reduced venous system resistance (venous pooling), producing a saving in cardiac work and a reduction in oxygen consumption by the myocardium. Transdermal systems perfectly adapt to the use of lipophilic drugs which act at very low plasma levels, as is the case with nitroglycerin.

Active ingredient

NITRO-PATCH

Nitrofix

The Nitro-patch is a small bioengineering masterwork, capable of releasing the drug into the organism at a controlled quantity and speed for a suitably set period of time, without the drawbacks which can often be associated with oral administration, such as a loss of pharmacological substances caused by the interference of foods and by the liver’s metabolism, as well as risks associated with omissions or self-regulation of the drug intake due to the number of administrations. Further, the active ingredient directly penetrates the blood for a prolonged period of time and without significant fluctuations, thereby avoiding congestion of the organism and ensuring it is not left unprotected by the drug's action after just a few hours, as may often occur with common pills. Systemic action transdermal band aid technology offers a means for constant drug administration over time. This facilitates a reduction in potential side effects and allows for increased tolerance of the cure by the patient. The active ingredient is in fact gradually inserted into the body's circulatory system.

DEVELOPMENT BRUNIFARMA'S PARTNERS

Brunifarma utilised the collaboration of Bouty Healthcare S.p.A. and I.P.A.S SA for the development and manufacture of the Nitro-patch.

Bouty, a company with proven experience in the pharmaceutical industry since the beginning of the 1900s, has maximised its already acquired skills whilst at the same time developing new methods of research in the field of Drug Delivery Systems, including systemic action transdermal band aids such as the Nitro-patch.

I.P.A.S., CRO, founded in 1993 and an expert in Phase 1 and Bioequivalence studies, carrying out an average of approximately 40/45 studies per year upon the request of more than 50 international sponsors, has confirmed all the above mentioned pharmacological and pharmacokinetic features of the product.

The Brunifarma Nitro-patch has been marketed in Spain by one of our partners, Arafarma Group, as the first branded generic transdermal band aid, by the name Nitrofix™. The nitroglycerin band aid has been marketed in Italy by other Brunifarma partners, all of which are leading companies in the cardiovascular field.

IPASBoutyArafarma