Innovation | galenic form via the per-mucous gingivo-jugal route

MELATONIN, DOXYLAMINE, FLUNITRAZEPAM AND MIDAZOLAM VIA THE PER-MUCOUS BUCCAL ROUTE, Allowing instant aCTION ON THE CENTRAL NERVOUS SYSTEM.

The innovation is based on the administration of the lipophilic neurotropic active ingredients via the trans-mucous buccal route, thereby providing them with unrivalled therapeutic power in terms of dose-effect, speed of action, tolerance and therapeutic modulability, thus offering fast and enhanced efficacy at reduced dosage.

The innovation is protected under French patent no. FR 1350308 and PCT no. FR 2014/050070, covered by international extensions in Europe, Brazil, Canada, Indonesia, India, Mexico, Russia, China, Japan and the USA, “Galenic form for the oral transmucosal administration of an active ingredient for accelerated induction of sleep and/or the treatment of sleep disorders and/or the treatment of a central nervous system attack”, for which JKphArma Galenic Innovation holds the exclusive operating licence.

SETRONS VIA THE PER-MUCOUS BUCCAL ROUTE

Dedicated to specific Anti-Emetic Treatment in Oncology, thereby providing unrivalled therapeutic power in terms of simplicity of administration, speed of action, tolerance and enhanced efficacy at reduced dosages.

The innovation is protected by French patent no. FR 08/7258 and PCT no. WO 2010/070236 A1, covered by international extensions in Europe, China, Japan, Russia, Canada, Brazil, India and the USA: “Formulation for the transmucosal administration of at least one active principle from the family of Setrons”, for which JKphArma Galenic Innovation holds the exclusive operating licence.

STATINS VIA THE PER-MUCOUS BUCCAL ROUTE

Dedicated to treatments for hypercholesterolaemia and in the prevention of myocardial infarction, providing them with unrivalled therapeutic power in terms of simplicity of administration, speed of action, tolerance and enhanced efficacy at reduced dosage.

The administration of Pravastatin directly into the circulation at low useful dosages is an unrivalled means of enhancing systemic tolerance and obtaining improved cardio-vascular efficacy for this Statin.

The innovation is protected by French patent no. FR 08/58947 and PCT no. WO 2010/072950 A1, covered by international extensions in Europe, Brazil, Indonesia, India, Mexico; “Formulation for the transmucosal administration of at least one active principle from the family of Statins”, for which JKphArma Galenic Innovation holds the exclusive operating licence.

TRIPTANS VIA THE PER-MUCOUS BUCCAL ROUTE

Dedicated to acute treatment of migraine, the technology application to Triptans clinically demonstrated the instant treatment of the “cluster deadache” neurologic emergency at low while effective dosages of Sumatriptan (only 2 mg and 4 mg), thus providing an unrivalled therapeutic power in terms of speed of action, tolerance and enhanced efficacy at reduced dosage.

The innovation is protected by PCT patent no. WO 2009/095621 A1, covered by numerous international extensions; “Formulation for the transmucosal administration of at least one active principle from the family of Triptans”, for which JKphArma Galenic Innovation holds the exclusive operating licence.

ADDED VALUE OF THE “PER-MUCOUS GINGIVO-JUGAL” (B.P.M.®) TECHNOLOGY

The invention is “per-mucous gingivo-jugal” (or B.P.M.® for Buccal Per Mucous) technology, concerning the galenic form that offers instantaneous systemic administration of a lipophilic active ingredient via the buccal trans-mucous route.

The galenic form is a hydro-alcoholic solution containing between 40% and 65% Ethanol by mass and between 35% and 60% water by mass. If required, the hydro-alcoholic solution may also contain a pH adjustment agent.

This specific, strictly hydro-alcoholic medium enables the dissolved lipophilic molecules to be turned into a smaller, slightly wetted molecule  that can rapidly cross the lipophilic buccal mucous membrane. These new structures of active ingredient have demonstrated specific affinity and the capacity to be transported faster across the blood-brain barrier. The B.P.M.® low dosages were clinically demonstrated to be as effective as a 8 times higher dosage administered by intravenous route.

This B.P.M.® highly innovative galenic form enables the active ingredient to act on the receptors of the central nervous system, rapidly obtaining pharmacodynamic efficacy by exploiting very low effective dosages of the active ingredients.

JKphArma Galenic Innovation holds several exclusive operating licences for the application of the B.P.M.® “per-mucous gingivo-jugal” technology, applied to the following CNS drugs :

  • Doxylamine for sleep disorders
  • Flunitrazapam for severe sleep disorders
  • Melatonin for sleep disorders
  • Midazolam for treating episodes of epilepsy and convulsions
  • Midazolam for pre-anaesthetic and pre-medication treatment
  • Setrons in the prevention of post-chemotherapy nausea
  • Statins in the treatment of hypercholesterolaemia and the prevention of myocardial infarction
  • Triptans in the acute treatment of migraine episodes

THE BUCCAL PER-MUCOUS ROUTE or “BPM®”

Offering instantaneous systemic bioavailability and becoming rapidly effective at very low useful dosages, it has already been clinically demonstrated and compared to the other usual injectable forms as described in the following publications :

LITERATURE ON THE PER-MUCOUS GINGIVO-JUGAL FORM

 

 POSTER 1 | European Association for Clinical pharmacology and Therapeutic EACPT Geneva 2013

 POSTER 2 | Société Française d’Evaluation et Traitement de la Douleur Nov 2014

 REF. 1 | Buccal Per-Mucous Sumatriptan Study CEPHALAGIA

 REF. 1 | Drug Design Development & Therapy 63476 Buccal Acetaminophen provides fast analgesia two randomised 092614

 REF. 2 | POSTER SUMATRIPTAN Cluster Headache

 REF. 2 | Publication PAIN PHYSICIAN Buccal Per-Mucous Acetaminophen