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US-12616655-B2 - Topical antibiotic containing pharmaceutical composition for bacterial infections and wound healing

US12616655B2US 12616655 B2US12616655 B2US 12616655B2US-12616655-B2

Abstract

A Pharmaceutical composition for treating bacterial skin infections, burns and wounds is disclosed. It comprises an active ingredient, preferably Mupirocin, a biopolymer, preferably Chitosan, with molecular weight ranging from 250,000 Da to 600,000 Da, and a degree of deacetylation of not less than 80%, hydrolyzed Collagen, preferably of type I, with molecular weight ranging from 3 kDa to 6 kDa, and an ointment base comprising emulsifying agents, glycols and solubilizers. The invention has improved stability than the existing ointments, it heals skin and re-epithelializes faster than existing treatments thereby reducing hospitalisation period.

Inventors

  • Vishagan Vanangamudi Sulur
  • Vanangamudi Subramaniam Sulur
  • Madhavan Srinivasan

Assignees

  • Vishagan Vanangamudi Sulur

Dates

Publication Date
20260505
Application Date
20201019
Priority Date
20191024

Claims (19)

  1. 1 . A pharmaceutical composition for bacterial infections and wound healing, characterised in that said pharmaceutical composition comprises following components: a topical antibiotic pharmaceutically active agent; a biopolymer; hydrolysed collagen of type I; and an ointment base; wherein all components are mixed homogeneously to form an ointment of pH value between 6.8 and 7.2; wherein said topical antibiotic pharmaceutically active agent is Mupirocin present in an amount between 0.1% (w/w) to 5% (w/w); wherein said biopolymer is Chitosan present in an amount between 0.01% (w/w) to 0.5% (w/w); and wherein said hydrolyzed collagen of type I is present in an amount of from about 0.01 (w/w) and 0.5% (w/w).
  2. 2 . The pharmaceutical composition as claimed in claim 1 , wherein said ointment base comprises: one or more waxy materials, one or more co-solvents, one or more acids, one or more thickeners, one or more preservatives, one or more chelating agents, one or more humectants, and water, wherein the one or more waxy materials comprise at least one of Polyethylene Glycol (PEG) 400, PEG 500, PEG 1000, PEG 1200, PEG 1500, PEG 1800, PEG 2000, PEG 2200, PEG 3550, or PEG 4000, and wherein the one or more waxy materials are present in an amount between 5% (w/w) to 80% (w/w), wherein the one or more co-solvents comprise at least one of: Propylene Glycol, Hexylene Glycol, PEG 200, PEG 300, PEG 400, or PEG 500, and wherein the one co-solvents are present in an amount between 5% (w/w) to 80% (w/w), wherein the one or more acids comprises at least one of: HCl, H 2 SO 4 , HNO 3 , or Lactic acid, and wherein the one or more acids are present in an amount between 0.005% (w/w) to 1% (w/w), wherein the one of more thickeners comprises at least one of: Acrylamide/Sodium AcryloyldimethylTaurate Copolymer/Isohexadecane & Polysorbate 80, Microcrystalline Cellulose, Carboxymethyl Cellulose, Hydroxypropyl Methyl Cellulose, or Ethyl Cellulose and wherein the one or more thickeners are present in an amount between 0.05% (w/w) to 10% (w/w), wherein the one or more preservatives comprise at least one of: Methylparaben, Propylparaben, Chlorocresol, or Potassium sorbate, and wherein the one or more preservatives are present in an amount between 0.05% (w/w) to 2.0% (w/w), wherein the one or more chelating agents comprise Disodium EDTA, and wherein the one or more chelating agents are present in an amount between 0.05% (w/w) to 1% (w/w).
  3. 3 . The pharmaceutical composition as claimed in any one of claim 1 or 2 , wherein said chitosan has a degree of deacetylation of no less than 70%.
  4. 4 . The pharmaceutical composition as claimed in any one of claim 1 or 2 , wherein said chitosan has a bacterial endotoxin level of 100 IU/g.
  5. 5 . The pharmaceutical composition as claimed in any one of claim 1 or 2 , wherein said chitosan has a molecular weight in the range between 250,000 Da to 600,000 Da.
  6. 6 . The pharmaceutical composition as claimed in claim 1 , wherein said topical antibiotic pharmaceutically active agent is Mupirocin present in an amount of 2% (w/w).
  7. 7 . The pharmaceutical composition as claimed in claim 1 , wherein said biopolymer is Chitosan present in an amount of 0.05% (w/w).
  8. 8 . The pharmaceutical composition as claimed in claim 1 , wherein said hydrolyzed collagen of type I is present in an amount of 0.05% (w/w).
  9. 9 . The pharmaceutical composition as claimed in claim 3 , wherein said chitosan has a degree of deacetylation of no less than 80%.
  10. 10 . The pharmaceutical composition as claimed in claim 1 , wherein said ointment base comprises one or more waxy materials, one or more co-solvents, one or more acids, one or more thickeners, one or more preservatives, one or more chelating agents, one or more humectants, and water.
  11. 11 . The pharmaceutical composition as claimed in claim 10 , wherein the one or more waxy materials are present in an amount between 5% (w/w) to 80% (w/w); wherein the one or more co-solvents are present in an amount between 5% (w/w) to 80% (w/w); wherein the one or more acids are present in an amount between 0.005% (w/w) to 1% (w/w); wherein the one or more thickeners are present in an amount between 0.05% (w/w) to 10% (w/w); wherein the one or more preservatives are present in an amount between 0.05% (w/w) to 2.0% (w/w); and wherein the one or more chelating agents are present in an amount no greater than 1% (w/w).
  12. 12 . The pharmaceutical composition as claimed in claim 11 , wherein each of the one or more waxy materials is selected from the group consisting of: PEG 400, PEG 500, PEG 1000, PEG 1200, PEG 1500, PEG 1800, PEG 2000, PEG 2200, PEG 3550, PEG 4000, and combinations thereof; wherein each of the one or more co-solvents is selected from the group consisting of: Propylene Glycol, Hexylene Glycol, PEG 200, PEG 300, PEG 400, PEG 500, and combinations thereof; wherein each of the one or more acids is selected from the group consisting of: HCl, H 2 SO 4 , HNO 3 , Lactic acid, and combinations thereof; wherein each of the one or more thickeners is selected from the group consisting of: Acrylamide/Sodium AcryloyldimethylTaurate Copolymer/Isohexadecane & Polysorbate 80, Microcrystalline Cellulose, Carboxymethyl Cellulose, Hydroxypropyl Methyl Cellulose, Ethyl Cellulose, and combinations thereof; wherein each of the one or more preservatives is selected from the group consisting of: Methylparaben, Propylparaben, Chlorocresol, Potassium sorbate, and combinations thereof; and wherein each of the one or more chelating agents is Disodium EDTA.
  13. 13 . The pharmaceutical composition as claimed in claim 1 , wherein the Mupirocin has a molecular weight of about 500.6 grams per mol (g/mol).
  14. 14 . The pharmaceutical composition as claimed in claim 3 , wherein said chitosan has a bacterial endotoxin level of 100 IU/g.
  15. 15 . The pharmaceutical composition as claimed in claim 3 , wherein said chitosan has a molecular weight in the range between 250,000 Da to 600,000 Da.
  16. 16 . The pharmaceutical composition as claimed in claim 4 , wherein said chitosan has a molecular weight in the range between 250,000 Da to 600,000 Da.
  17. 17 . The pharmaceutical composition as claimed in claim 1 , wherein said pharmaceutical composition has a water content of no greater than 2% (w/w).
  18. 18 . The pharmaceutical composition as claimed in claim 1 , wherein the ointment base is a non-aqueous ointment base.
  19. 19 . The pharmaceutical composition as claimed in claim 1 , wherein said hydrolyzed collagen of type I is present in an amount of 0.5% (w/w).

Description

FIELD OF INVENTION The present invention relates to a Pharmaceutical composition for bacterial infections and wound healing. In particular, the invention relates to a pharmaceutical composition comprising an topical antibiotic pharmaceutically active agent; a biopolymer; hydrolysed collagen of type I; and an ointment base. BACKGROUND OF THE INVENTION The skin is the body's first barrier against bacteria that cause infections. Bacterial skin infections can affect a small spot or may spread, affecting a large area. They can range from a treatable infection to a life threatening skin condition. Common skin infections include cellulitis, erysipelas, impetigo, folliculitis and furuncles and carbuncles. Cellulitis is an infection of the dermis and subcutaneous tissue that has poorly demarcated borders and is usually caused by Streptococcus or Staphylococcus spp. Erysipelas is a superficial form of cellulitis with sharply demarcated borders and is caused almost exclusively by Streptococcus. Impetigo is also caused by Streptococcus or Staphylococcus and can lead to lifting of the stratum corneum resulting in the commonly seen bullous effect. Folliculitis is an inflammation of the hair follicles. When the infection is bacterial rather than mechanical in nature, it is most commonly caused by Staphylococcus. If infection of the follicle is deeper and involves more follicles, it moves into the furuncle and carbuncle stages and usually requires incision and drainage. All of these infections are typically diagnosed by clinical presentation and treated empirically. Wounds are heterogeneous and the wound healing process is of a multifactorial nature, influenced by many factors and compounds introduced externally. The definition of wound pharmacology is the study of agents and their actions in wound environment. Three classes of agents are used in wound healing treatment. They are drugs, biologics and special biologics such as those produced by biotechnology. These agents come under the group of pharmacological products. The group of non-pharmacological products consist products with no direct pharmacological effect on wound healing. These can be divided into interactive and passive materials. Numerous treatments both topical and systemic are currently employed for the treatment of primary, secondary bacterial infections, caused by gram +ve and gram −ve organisms, and for burns and wound healing. Topical and systemic bacterial infection treatment composition typically employs an active ingredient in combination with a carrier component. The active ingredients typically comprise an antibiotic/antibacterial such as Mupirocin, Fusidic Acid, Sodium Fusidate, Benzyl Benzoate, Tetracyclines, Neomycin, Gentamycin, Framycetin, Sisomicin, Ciprofloxacin, Povidine-Iodine and the like. Primary Infections: Three forms of impetigo are recognized on the basis of clinical, bacteriologic, and histologic findings. The lesions of common or superficial impetigo may contain group A β-hemolytic streptococci, S. aureus or both, and controversy exists about which of these organisms is the primary pathogen. The lesions have a thick, adherent, recurrent, dirty yellow crust with an erythematous margin. This form of impetigo is the most common skin infection in children. Impetigo in infants is highly contagious and requires prompt treatment. The lesions in bullous (staphylococcal) impetigo, which are always caused by S aureus, are superficial, thin-walled, and bullous. When a lesion ruptures, a thin, transparent, varnish like crust appears which can be distinguished from the stuck on crust of common impetigo. This distinctive appearance of bullous impetigo results from the local action of the epidermolytic toxin. Ecthyma is a deeper form of impetigo. Lesions usually occur on the legs and other areas of the body that are generally covered, and they often occur as a complication of debility and infestation. The ulcers have a punched out appearance when the crust or purulent materials are removed. The lesions heal slowly and leave scars. Streptococcus pyogenes is the most common agent of cellulitis, a diffuse inflammation of loose connective tissue, particularly subcutaneous tissue. No absolute distinction can be made between streptococcal cellulitis and erysipelas. Clinically, erysipelas is more superficial, with a sharp margin as opposed to undefined border of cellulitis. Folliculitis can be divided into two major categories on the basis of histologic location: Superficial and deep. The most superficial form of skin infection is staphylococcal folliculitis manifested by minute erythematous follicular pustules without involvement of the surrounding skin. In deep folliculitis, infection extends deeply into the follicle and the resulting perifolliculitis causes a more marked inflammatory response than that seen in superficial folliculitis. In sycosis barbae (barber's itch), the primary lesion is a follicular pustule pierced by a hair. Bearded men may be m