Betamethasone Valerate & Neomycin Sulfate Cream

Betamethasone Valerate & Neomycin Sulfate Cream

Patented Cream formulation of Betamethasone Valerate and Neomycin Sulfate Cream with Chitosan Biopolymer.

Proprietary, Patent Protected Product.

The present invention is a patented cream formulation of Active Pharmaceutical Ingredients Betamethasone Valerate and Neomycin Sulfate containing Chitosan Biopolymer for treating corticosteroid-responsive dermatoses with secondary infection.

Betamethasone Valerate and Neomycin Sulfate Cream with Chitosan Biopolymer has been granted patent in US (US 8,546,362 B2).

Betamethasone Valerate

Betamethasone is a potent topical corticosteroid used for treating inflammatory and pruritic manifestation of corticosteroid-responsive dermatoses. Betamethasone with its anti-inflammatory, anti-pruritic and vasoconstrictive action reduces swelling, redness and itch by modifying the functions of epidermal and immune cells participating in inflammatory skin diseases. Betamethasone is very effective in treating patches of dermatitis flare up and short courses of Betamethasone are prescribed for the treatment of psoriasis for small areas such as the scalp, soles of the feet and palms of the hands.

Neomycin Sulfate

Neomycin is an antibiotic that belongs to the aminoglycoside classification. Neomycin works by binding to the bacterial 30s ribosomal subunit, causing misreading of t-RNA, leaving the bacterium unable to synthesize proteins vital to its growth resulting in the death of bacteria, which are sensitive to the antibiotic. It is active against some aerobic gram-positive and multiple aerobic gram-negative bacteria. Neomycin is the most commonly used topical antibiotic in the United States and in many European countries. Bacteria also involve in induction and aggravation of inflammatory skin diseases.

The combination of Betamethasone valerate with Neomycin sulfate cream is indicated for the treatment of corticosteroid-responsive dermatoses with secondary infection.

Chitosan Biopolymer

Chitosan is a linear polysaccharide composed of randomly distributed β-(1-4)-linked D-glucosamine (deacetylated unit) and N-acetyl-D-glucosamine (acetylated unit). In medicine, it is useful in bandages to reduce bleeding, hastens healing and as an antibacterial agent it can also be used to help deliver drugs through the skin.

Chitosan’s properties allow it to rapidly clot blood and have recently gained approval in the United States and Europe for use in bandages and other hemostatic agents. Chitosan hemostatic products have been shown in testing by the U.S. Marine Corps to quickly stop bleeding and to reduce blood loss.

Benefits of Chitosan Biopolymer

Chitosan’s known properties of binding with red blood cells helps in accelerating blood clotting. It is known to have film-forming, mucoadhesive and viscosity-increasing properties. It is biocompatible with both healthy and infected skin and has been shown to be biodegradable.

  • Chitosan Biopolymer significantly ensures greater efficacy in improving steroid flux and accumulation into the Stratum corneum and epidermis and sustained release of the steroid was achieved with the use of chitosan as a vehicle.
  • Chitosan Biopolymer demonstrates properties that favor repair and remodeling of damaged skin, stimulates dermal fibroblast cellular activities and facilitates retention of fibroblast growth factors, thereby restores the native skin in inflammatory skin diseases.
  • Chitosan Biopolymer improves the skin barrier function and inhibits itch-related scratching accompanied by barrier-disruption.
  • Chitosan Biopolymer with its natural cationic charge acts as broad spectrum bactericidal agent which immobilizes arrests and kills the bacteria at the site of application by penetrating intact, damaged skin, crust and cellular debris and forms biodegradable mesh. Chitosan reported to act as a bactericidal agent by a three-way mechanism, hence found to be effective against resistant pathogens.
  • As a micro-film forming biomaterial, controls the oxygen permeability at the site, absorbs skin discharge and gets degraded by tissue enzymes which are very much required for skin restoration. It also reduces the skin irritation, and reported to be preventing secondary infection and prevention of Staph. aureus colonization in dry skin disorders.

 

Synergistic Advantage of Betamethasone Valerate and Neomycin Sulfate Cream with Chitosan Biopolymer

Chitosan Biopolymer as a broad spectrum bactericidal agent complements Neomycin Sulfate. Chitosan Biopolymer found to reduce side effects of Neomycin Sulfate such as hypersensitive reactions, rashes, itching, burning sensation caused by the use of conventional Neomycin preparations.

Chitosan Biopolymer with its natural positive charge ensures excellent contact surface over the entire application area which ensures sustained and localized delivery of Betamethasone Valerate and Neomycin Sulfate.

Betamethasone Valerate and Neomycin Sulfate Cream with Chitosan Biopolymer forms a micro bio-film at the site of wound which helps in reducing the width of the wound, absorbs wound discharge and gets degraded by tissue enzymes which are very much required for healing at a faster rate.

Proof of Concept

The proof of concept for the uniqueness of patented formulation was provided through a series of trials conducted at USFDA approved and internationally accredited Clinical Research Organizations and Academic Institutions. The details of clinical trials are furnished below;

Study on Blood Clotting – Micro Therapeutic Research Labs (USFDA Approved), Chennai, India

The clinical trial confirms that, Betamethasone Valerate and Neomycin Sulfate Cream with Chitosan Biopolymer was effective in reducing the blood clotting time by 37.50%.

Proof of Higher Efficacy – Quest Life Sciences (USFDA Approved), Chennai, India

Clinical trial on the parameters of patient comfort and skin rejuvenation with Betamethasone Valerate and Neomycin Sulfate Cream with Chitosan Biopolymer were measured and found superior to Betamethasone with Neomycin Cream alone.

Preservative Efficacy Test – Micro Therapeutic Research Laboratories (USFDA Approved), Chennai, India

Preservative efficacy test was conducted on bacteria, yeast & moulds and it has been confirmed to U.S.P. Criteria.

Safety and Tolerance Test – Kasturba Medical College and Hospital, Manipal, India

In the treatment of eczema Betamethasone Valerate and Neomycin Sulfate Cream with Chitosan Biopolymer showed improvement in the scores of Visual Analogue Score (VAS), Global Score Index (GSI) & & Mean Eczema Area and Severity Index (MEASI) when compared to Betamethasone and Neomycin Cream alone.

BIOCHITODERM™ is the registered trademark of apex in India representing the Biopolymer Chitosan used in different products by apex as a functional excipient along with various Active Pharmaceutical Ingredients (API).