THE PROBLEM:

In dermatology, many  actives are prescribed in combination. However, some do interact with each other and therefore cannot be formulated together. Sometimes a restrictive cold chain storage and distribution system can be the only compromise but still with serious limitations like a requirement for the combination to be reconstituted at the point of sale.. With certain combinations, it is not even possible to bring two actives together under any circumstances.

THE SOLUTION:

A novel and unique method to dispense two different and incompatible semi-solids onto the skin.

A unique and patented Dual Chamber Dispensing system specially designed for Pharmaceutical use.

FEATURES:

Design:

-Constructed with polycarbonate and surgical quality Stainless Steel necessary for fully protecting peroxides and acids.

-Two independent modular pump mechanisms (Manufactured by a specialized pump manufacturer) on separate chambers enabling dosing with high accuracy and reproducibility.

-Fixed dose dispensing, manufacturer adjustable for each side. No user adjustments possible.

-Independent  (Dual plungers) or simultaneous  (Single plunger) delivery.

-Tamper-Proof dispensing system.

-Two Different Sizes (15ml X 2) and (30ml X 2) readily available. Additional sizes possible.

-510(K) Application in the USA has been approved.

TECHNOLOGY DIFFERENTIATION:

Formulations using topical Polymeric Delivery System (PDS) with similar vehicles for Sustained Equilibrated Delivery (SED) using the Dual Chamber Dispenser have been developed. Use of the PDS in this dispenser is patent pending and gives these formulations certain unique properties:

• Fewer daily doses (once daily)
• Better patient compliance
• Reduced Irritation
• Enhanced Stability (Retinoids)

COMPLIANCE WITH FDA MONOGRAPHS:

Using conventional (Non-PDS) or PDS formulations (with some restriction on claims), the Dual Plunger system allows for labeled alternate use. (Day and Night). This product would not require previous FDA approval and can be marketed very rapidly without a large investment of time and money.

EXTENDED SHELF LIFE AND NO COLD CHAIN STORAGE OR COLD CHAIN DISTRIBUTION:

Lower overall costs and no distribution constraints whatsoever.

FORMULATIONS BEING DEVELOPED:

OTC:

-Benzoyl Peroxide 6% / Salicylic Acid 2% or 4% (Developed)

-Hydroquinone / Retinol

-Benzoyl Peroxide / Retinol

RX:

-Benzoyl Peroxide 6% / Clindamycin 2% (Developed)

-Tretinoin/ Clindamycin

1-INTELLECTUAL PROPERTY (IP) PROTECTION:

Dual Chamber Container (Level 1):

Manufacturer has a US patent portfolio on the unique design of the container.

Formulations (Level 2):

Patents covering formulations using topical Polymeric Delivery System (PDS) with vehicles designed for Sustained Equilibrated Delivery (SED) have been applied for. Wide spectrum of combinations have been covered.

2-WORLDWIDE DISTRIBUTION PROTECTION:

Exclusive worldwide distribution rights for Pharmaceutical and OTC use are available from the distributor.

3-TECHNOLOGY PLATFORM PROTECTION:

Use of SIMUPUMP® and DUOPUMP® Trade Marks in the USA are available.

Licensing out of dual chamber container use (Rx and OTC), technology and/or products on a worldwide basis.