Silver Sulfadiazine Cream

Silver Sulfadiazine Cream

Patented Silver Sulfadiazine Cream with Chitosan Biopolymer.

Proprietary, Patent Protected Product.

The present invention is a patented cream formulation of an Active Pharmaceutical Ingredient Silver Sulfadiazine containing Chitosan Biopolymer for treating burn wounds, chronic ulcers, pressure ulcers and bacterial skin infections.
Silver Sulfadiazine with Chitosan Biopolymer Cream has been granted patent in US (US 9,044,488 B2).

Silver sulfadiazine

Silver sulfadiazine is a broad antimicrobial agent. It is active against gram-positive and gram-negative bacteria and also on some yeasts and fungi. The silver salt acts mainly on the cell wall and membrane to disrupt its integrity thus allowing it to impair the essential enzymes, bacterial DNA and RNA leading to cell death.

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 and 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 include acceleration of blood clotting. It is known to have film forming, mucoadhesive and viscosity-increasing properties. It is biocompatible with both healthy and infected skin and is biodegradable.

  • Chitosan Biopolymer acts as a vehicle in the localized delivery of Active Pharmaceutical Ingredients thereby increasing the permeability and availability of the active ingredient in the skin.
  • As a micro-film forming biomaterial, Chitosan Biopolymer found to help in reducing the width of the wound, controls the oxygen permeability at the site, absorbs wound discharge and gets degraded by tissue enzymes which are very much required for healing at a faster rate. It also reduces the skin irritation and reported to be preventing secondary infection.
  • Chitosan Biopolymer with its natural cationic charge acts as a 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 by a three way mechanism, hence found to be effective even against resistant pathogens.
  • Chitosan Biopolymer has been studied and widely published in reputed medical journals as a wound healing accelerator in all phases of wound healing and beneficial in reducing scar tissue formation by biphasic regulation of TGF-Beta which helps to rejuvenate and restore the native skin in burn wounds.

Synergistic Advantage of Silver Sulfadiazine Cream with Chitosan Biopolymer

In burn wounds, chronic ulcers, bedsores and all bacterial infections, Silver Sulfadiazine Cream with Chitosan Biopolymer is the first ever topical antibiotic cream which ensures superior skin healing and rapidly restores native skin.

Chitosan biopolymer as a broad spectrum bactericidal agent complements the Silver Sulfadiazine.

Silver Sulfadiazine Cream with Chitosan Biopolymer had greater release profile and release rate of silver ions 22.88% compared to marketed silver
sulfadiazine gel.

Silver Sulfadiazine 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.

Silver Sulfadiazine Cream with Chitosan Biopolymer ensures quick onset of healing and more percentage of healing, re-epithelialization and wound closure in Day 4 compared with silver sulfadiazine gel.

Proof of Concepts

The proof of concept for the uniqueness of patented formulation was provided through a series of trials conducted at USFDA approved Clinical Research Organizations of repute. 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, Silver Sulfadiazine Cream with Chitosan Biopolymer was effective in reducing the blood clotting time by 35.91%.

Diffusion Study – Dr. BhanubenNanavati College of Pharmacy, Mumbai, India

The study reveals that the rate of diffusion and release rate/flux rate of Silver Sulfadiazine Cream with Chitosan Biopolymer was 22.88% in comparison to a flux rate of 10.98% of market lead comparable product.

Skin Irritation study- Micro Therapeutic Research Labs (USFDA Approved), Chennai, India

Silver Sulfadiazine Cream with Chitosan Biopolymer is Non-irritant to the skin as observed in the study when compared to marketed equivalent product at 72 hrs time point of observation.

Burn wound healing activity – Manipal Acunova Clinical Research Centre (USFDA Approved), Manipal, India

Silver Sulfadiazine Cream with Chitosan Biopolymer significantly ensures wound contraction on day 16 with percentage of 91.40% compared to Silver Sulfadiazine alone. Silver Sulfadiazine Cream with Chitosan Biopolymer not only clears the infection but also favors healing of burn wounds.

Clinical study on second and third degree burns – Quest Life Sciences (USFDA Approved), Chennai, India

In second and third degree burns Silver Sulfadiazine Cream with Chitosan Biopolymer accelerated wound closure and scored higher on the following parameters as compared to the Silver Sulfadiazine gel.

  • Visual analogue score
  • Wound Closure
  • Physician’s global evaluation score
  • Patient compliance

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

Silver Sulfadiazine Cream with Chitosan Biopolymer passes the antimicrobial preservative efficacy test as per the U.S.P. Criteria.

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).