Debriding composition from bromelain and methods of production thereof
Inventors
Assignees
Publication Number
US-8540983-B2
Publication Date
2013-09-24
Expiration Date
2025-11-22
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Abstract
The present invention relates to a debriding composition obtained from bromelain and to methods of producing same. Particularly, the present invention relates to a debriding composition obtained from bromelain comprising proteolytic enzymes having molecular weights of about 23 kDa, being essentially devoid of bromelain inhibitors, and to pharmaceutical compositions comprising same. The debriding compositions and the pharmaceutical compositions comprising same are particularly useful in debriding eschar tissues and in wound healing.
Core Innovation
The invention relates to a debriding composition obtained from bromelain, comprising proteolytic enzymes having molecular weights of about 23 kDa and being essentially devoid of bromelain inhibitors. It also includes methods for producing this composition and pharmaceutical compositions containing it. This composition is particularly useful in debriding eschar tissues and promoting wound healing.
The problem addressed stems from previous difficulties in developing effective enzymatic debriding agents that remove devitalized tissue without surgery. Existing proteolytic enzyme preparations either suffer from poor efficacy, toxic side effects, lack selectivity, or contain bromelain inhibitors that reduce their activity. There is a need for a biochemically characterized enzyme mixture from bromelain that is essentially devoid of inhibitors and contains most proteolytic enzymes, resulting in efficient and reproducible debridement of non-viable tissues.
The invention discloses, for the first time, that by adding filter aid and filtration steps in the preparation method from bromelain, it is possible to obtain a highly efficient debriding composition substantially free of bromelain inhibitors. This composition predominantly contains proteins of about 23 kDa molecular weight, shows superior debridement activity compared to bromelain itself, and demonstrates reproducible protein content, making it advantageous for clinical applications.
Claims Coverage
The patent includes four independent claims focusing on the composition, a pharmaceutical composition including the debriding composition, and methods of treating wounds by applying the composition. The inventive features focus on the composition's biochemical properties and its practical applications in wound treatment.
Debriding composition with specific proteolytic enzymes and minimal inhibitors
A debriding composition obtained from bromelain comprising a plurality of different proteolytic enzymes having molecular weights of about 23 kDa. This plurality comprises stem bromelain (SEQ ID No. 1), ananain (SEQ ID No. 2), stem bromelain (SEQ ID No. 3), and cysteine proteinase precursor (SEQ ID No. 4). The composition includes bromelain inhibitors in an amount less than 10% w/w of protein content and consists essentially of a single protein peak after elution from an HPLC size exclusion column TSK-Gel 3000SWXL representing proteins of about 23 kDa molecular weight.
Pharmaceutical composition including the debriding composition
A pharmaceutical composition composed of the debriding composition as defined above and a pharmaceutically acceptable carrier.
Method of treating wounds by applying the composition
A method of treating wounds by debriding non-viable tissues by applying a therapeutically effective amount of the debriding composition comprising the specific proteolytic enzymes with minimal bromelain inhibitors.
Method of treating wounds using the pharmaceutical composition
The method of treating wounds wherein the debriding composition is applied together with a pharmaceutically acceptable carrier.
Treatment of diverse wounds and lesions
The method wherein the wounds treated are selected from full and partial thickness burn wounds, sunburns, frostbite, ulcerative lesions including pressure, varicose, stasis, and trophic ulcers, wounds from surgical procedures such as amputation, incision, circumcision, episiotomy, traumatic and pyogenic wounds, vaginitis, cervicitis, pilonidal cyst wounds, cataract scar tissue, and skin graft sites.
The claims cover a defined bromelain-derived debriding composition characterized by proteolytic enzymes around 23 kDa and minimal inhibitors, pharmaceutical formulations including this composition, and methods of treating a wide variety of wounds using said composition, highlighting improved biochemical purity and therapeutic efficacy.
Stated Advantages
The debriding composition is highly efficient in the debridement of non-viable tissues compared to previously known bromelain preparations.
It has distinct and reproducible biochemical features, including being essentially devoid of bromelain inhibitors, resulting in superior and consistent activity for clinical use.
The composition can be formulated with pharmaceutically acceptable carriers suitable for various topical applications, enhancing practicality in medical treatment.
Documented Applications
Use in debriding devitalized tissues such as eschar from wounds.
Treatment and healing of a wide variety of wounds including full and partial thickness burn wounds, sunburns, frostbite, ulcerative lesions including pressure ulcers, varicose ulcers, stasis and trophic ulcers.
Treatment of wounds associated with surgical procedures such as amputation, incision, circumcision, and episiotomy.
Treatment of traumatic and pyogenic wounds, vaginitis, cervicitis, pilonidal cyst wounds, and cataract scar tissue.
Preparation and treatment of skin graft sites.
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