For Further Information Please Contact

Head, Business Processes Division,
CLRI, Adyar, Chennai 600 020.
Tel.:+91 44 2491 5238
email : e-mail :bpdclri@yahoo.com;
bpd@clri.res.in

Health Care Products

Wound Healing
 


A simple process for the purification of collagen using alcoholic solvents
Disclosed herein is a process for purification of collagen by alcoholic solvent precipitation method. This process provides more than 95% of yield and purity of collagen with less time and steps. A unique advantage of the process is that the production cost of pure collagen is reduced significantly compared to that in salt precipitation method especially because of less number of steps involved. The process finds potential application in the leather, cosmetic, biomedical materials, food and pharmaceutical industries for getting purer form of collagen. In pharmaceutical applications, pure collagen can be used for production of wound dressings, vitreous implants and as carriers for drug delivery. Indian Patent application no. is 201711010916.


An improved fibrin nanomaterial for biomedical applications and a process for the preparation thereof
Disclosed herein is an improved fibrin nanomaterial characterized by presence of Iodine group containing diatrizoic acid attached to the –NH2 group and amide bonds formed between amino groups of fibrin and carboxylic groups of iodinated diatrizoic acid molecules having diameter in range of 48 to 52 nm and exhibiting zeta potential value in the range of +10 to +14.8 mV. The said fibrin nanomaterial offers contrast enhancement for imaging methods and also delivers therapeutic agents such as chemotherapeutic drugs, monoclonal antibodies and nucleic acids to the site of infection/disease or cancer. In particular, the present invention relates to iodinated fibrin nanomaterial that shows simultaneous contrast for medical imaging modalities such as computed tomography and x-ray radiography. It is haemocompatible, cytocompatible and immunocompatible. It binds easily to αvβ3 integrin receptors, overexpressed on tumour cells and also facilitates delivery of chemotherapeutic drugs at the binding site. A simple process for the preparation of the nanomaterial is also disclosed. Indian Patent application no. is 201711000055.


A novel collagen suture material for biomedical applications and process for the preparation thereof
Disclosed herein is suture material, essentially collagenous, useful for wound healing and internal as well as external surgical applications. The unique feature of the suture is that it exhibits tensile strength as high as 65 - 85MPa that is retained for as long as six month period. A process for the preparation of the suture is also disclosed. The collagen suture material of the present invention finds large application in biomedical industry for the purpose of wound healing, external and internal surgeries. It provides an opportunity for utilization of the solid leather wastes generated by tanneries to make value added medical products for biomedical applications. Indian Patent application no. is 201611035850.


Collagenous cream composition for biomedical application and a process for the preparation thereof
Disclosed herein is a cost effective collagen based pharmaceutical cream composition, that promotes wound healing. It finds application in wound care management as well as drug delivery. The cream maintains water content for treating wounds effectively by mimicking extra cellular matrix of skin and normalizes the tissue-environment around the wound site. The composition promotes enhanced cellular activity. It is also able to stimulate the fibroblast growth as well as proliferation and hence it facilitates collagen production in wounded tissue. Indian Patent application no. is 3554DEL2015.


Fibrin nanoscaffold for biomedical applications and a process for the preparation thereof
The present invention relates to novel fibrin Nano scaffold useful for tissue engineering, gene/drug delivery and wound healing applications. It is biocompatible, non-toxic and exhibits excellent mechanical strength. Further, it increase cell proliferation and differentiation, thereby elucidating its potential application for tissue engineering and wound healing purposes. Each individual fibre of the Nano scaffold is ultrafine with diameter in the range of 50-100 nm. A simple, cost effective method for the preparation of the Nano scaffold is also provided. Indian Patent application no. is 3686DEL2015.

Collagen Based Biomaterial For Drug Delivery And Tissue Engineering And A Process For The Preparation Thereof
Disclosed herein is biomaterial comprising collagen, polysaccharide and polyphenol. It exhibits more biocompatibility and prolonged or enhanced stability against proteolytic enzymes. It is economical and safer for the tissue engineering and other biomedical applications. It can be designed into any physical states or shapes for different kind of applications like injectables, films, foams or other scaffold forms. This can also be used as carrier or vehicle for controlled drug delivery in disease treatment or growth factor delivery in tissue engineering. This also has scope for application in plastic surgery and as implants for the delivery of drugs in tumor treatment. (Indian Patent application no. 422Del2014.)


A Novel Collagen Hydrolysate Sponge Scaffold And A Proces For The Proeparation Thereof
Disclosed herein is a composite collagen hydrolysate sponge scaffold comprising collagen hydrolysate, chytosan and silica. It finds application in the biomedical materials. It exhibits porous morphology, good stability against collagenase degradation, better water uptake capaciy and antimicrobial property.The sponge can be used in tissue engineering as scaffold for tissue regeneration. It is very effective for the treatment topical wounds. (Indian patent application no. is 15Del2014.)

Novel Phytosome Nanoparticles Useful As Drug Carriers And Process For The Preparation Thereof
Disclosed herein is phytosome nanoparticle obtained by the combination of phospholipids with selected phytochemicals. These nanoparticles are safe, biocompatible, and are useful in targeted and controlled drug delivery system to combat infectious and cancerous cells.
(Indian Patent application no.2460Del2013)

Novel Fibrin Nanoparticles Useful For Tissue Engineering And Drug Delivery Applications And A Process For The Preparation Thereof
Disclosed herein is ultrafine fibrin nanoparticle in the size range 20-50 nm. It is stable and biocompatible. The particle finds use in tissue engineering and drug delivery applications. The process involves avoiding costly auxiliaries to make the product cost effective.
(Indian Patent application no.2010Del2013.)

A Novel Collagen Scaffold for Delivery of Multi-Therapeutics and a Process for the Preparation Thereof
This multi-layered scaffold could be applicable for tissue engineering/regeneration, drug delivery and wound dressing. This process may be used for phase-wise delivery of the growth factors which would be suitable for the studies of developmental biology. The novelty disclosed is the various ratios of the therapeutics/pharmaceuticals like antimicrobial agents, analgesics, antioxidants, antiallergic, growth factors and/or other signaling molecules like Lysophosphatidic acid (LPA), either in free form or microparticles encapsulated or combination of both can be taken to formulate the multi-layered porous scaffold with different concentrations of natural or chemically modified collagen. Microparticles comprise minimum of two types of polymers e.g. gelatin, chitosan, alginate, casein, PLGA, PCL and multi-layer scaffold contains at least two layers out of which one may be thin film layer without therapeutics, may act as a protective layer, which is desirable for wound dressing. The multi-layered porous scaffold prepared by homogenous casting of collagen solution on non-sticky substratum and allowed for semi-dry, similarly, the subsequent collagen layers were prepared and followed by freeze-dry or air-dry. In case of air-dry, the collagen solution was homogenized with surfactants like triton X-100. Cross-linking agents e.g. glutaraldehyde can be used to prolong the release of therapeutics. In the current product, therapeutics may be antibiotic(s) or analgesic(s) of growth factor(s) or any combinations for immediate and sustained/controlled delivery.
The invention has been applied for patent protection (Indian Patent application no. 672Del2011).

An improved process for the preparation of fibroplast
The fibroplast is non-immunogenic, semitransparent cover, which seals the wound while breathing like skin, thereby healing without scar formation. Collagenous substance, extracted from a collagenous source, is subjected to extensive purification to remove non-collagenous matters and the pure soluble collagen is cast into fibroplasts of desired size and shape. The resulting reconstituted fibroplast is subjected to crosslinking and sterilization. The product finds enormous application as a wound dressing aid for open wounds such as second degree burn, open raw surface, ulcers and the like. It enhances healing of wound, burn, excision wounds etc. Moreover, it prevents excessive evaporation of fluid and controls the infection. A unique feature of the product is that it exhibits better biocompatibility because of the purity of collagen. Further, the wound covered with a fibroplast can be inspected and monitored easily without removing it, because of the excellent transparency of the sheet. An Indian patent has been granted (Patent no. IN192397) for this invention. The technology has already been transferred and the product is also available in Indian market.

A process for the preparation of reconstituted collagen sponge
Pure collagenous substance is treated with surfactants in the presence of crosslinkers and pharmaceutically as well as pharmacologically active components under controlled conditions. The resulting mixture is lyophilized and sterilized. The surfactant enables the product to possess large pore structure capable of entrapping different drugs and controlled release of entrapped drugs is ensured. The product has potential application as wound dressing aid, bone-cartilage substitute, surgical tampons, laparatomy pads anda container for drug release. It serves as a better scaffolding for re-epithelization or good granulation of tissue to ensure faster recovery of wound as well as relief from pain. It prevents excess evaporation of fluid from wound ensuring minimum fluid loss from the wound site and also prevents any infection, thereby enhancing healing of wounds, burns, excision wounds. The invention has been applied for patent protection.(Indian Patent application no. 369Del2000, Patent pending).

An improved process for the preparation of collagen sponge
A process for the preparation of collagen sponge without lyophilisation is disclosed, whereby the collagen solution obtained from a conventional collagenous source is treated with a non-ionic wetting agent under specified conditions to enable the treated solution to be air dried, thereby reducing the high cost involved in conventional lyophilisation. It is envisaged to have enormous potential application in the pharmaceutical industry in preparing cost effective collagenous biomaterial useful for medical applications. The sponge obtained by this process can be used for different medical applications including burn management, wound cover, drug delivery device etc. The invention has been applied for Patent protection (Indian Patent application no. 461DEL2003;Patent pending)

A process for the preparation of plant based reconstituted collagen substratum
The process involves purification of proteolytic enzyme solubilized collagen and preparation of Aloe vera extract from its parenchymal tissue. The purified collagen and Aloe vera extract are mixed together and reconstituted. Subsequently, the solution mixture is spread to form sheets, followed by sterilization to obtain plant based reconstituted collagen substratum. The product finds potential medical application as biological cover for non-healing ulcers as well as burn injuries. The invention has been applied for Patent protection (Indian Patent application no. 84DEL2002; Patent pending).

A process for the preparation of reconstituted collagen substratum
The invention relates to the preparation of reconstituted collagen substratum from a human source. The process essentially involves isolation of Collagen Type IV, which is layered on the substratum made up of Type I & III collagen, thereby facilitating an efficient growth of keratinocytes. The product finds potential medical application as autograft for burn injuries of any degree. This may also be used as an effective permanent dressing material for wounds and burns. The major advantage of this product is that since it is prepared from human compatible source, no adverse/allergic reaction is envisaged at the human site of use and healing is expedited. The invention has been applied for Patent protection (Indian Patent application no. 709DEL2000; Patent pending).

A process for the preparation of biopolymer scaffold for medical applications.
The invention relates to a scaffold to aid in the tissue regeneration of tissue, such as bone, cartilage or soft tissue and as a container for delivery of bioactive molecules like growth factors. The scaffold is formed by the combination of the soluble biopolymer with a glycol, alkaline earth metal chloride and a cross linker. It comprises a polymer network having active agents, such as wound healing agents, incorporated therein. The compositions are suitable for use as or in wound dressings as it comprises methods and compositions for treating wounds. The matrix may be formed into any desired shape for treatment of wounds. The composition comprises a single density foam, either with or without cell seeding, which is not freeze dried, can be used to build living tissue equivalents or model tissue systems. Indian Patent has been granted for the invention (Indian Patent No. 199822).

A process for the preparation of a novel collagen scaffold useful for wound dressing.
The process involves purification of collagen from fetal calfskin by conventional method. Development of antibacterial agent loaded alginate microsphere by water/oil emulsion technique through ionic gelation of alginate, thus entrapping antibacterial agent in the alginate polymer matrix followed by rigidization and drying of the drug loaded microspheres. The prepared drug loaded microsphere was impregnated in the prepared collagen and subsequently initiating fibrillation. The drug impregnated fibrillated collagen was cast as a thin scaffold under controlled temperature and aseptic environment. The developed novel collagen scaffold impregnated with antibacterial agent delivers the drug in a controlled manner thus reducing frequency of dressing and makes wound assessment easier. The invention has been applied for Patent protection (Indian Patent application no. 314DEL2004;Patent pending).

A process for the preparation of collagen-chitosan bilayer material.
Collagen purified to the necessary extent (with or without telopeptide) in acid soluble form at a concentration of 1-10 mg/ml is made to gel around physiological conditions and crosslinked with appropriate chemicals in very low concentrations of 10-5 to 10-2 percent. An attachment to a layer of chitosan is effected at the same time resulting in a bilayer material. The composite matrix is further processed as appropriate to make four types of bilayer matrices ie. collagen film – chitosan film, collagen sponge – chitosan film, collagen film – chitosan sponge and collagen sponge – chitosan sponge. The bilayer material is envisaged to have enormous application in pharmaceutical industry as wound healing agent. It also finds potential application in biomedical area as efficient tissue engineering matrix. The invention has been applied for Patent protection (Indian Patent application no. 321DEL2004;Patent pending).

A process for extraction of atelopeptide collagen from a collagenous source by microbial treatment.
The invention relates to an extraction process to derive collagen fibres of high tensile strength from collagenous tissue. This microbial extraction procedure ensures degradation of non-collagenous components, leaving the collagenous matter intact. The resulting atelopeptide collagen exhibits largely monomeric triple helical conformation.The collagen is rendered non-immunogenic by the removal of certain terminal peptide chains. The non-cytotoxic fibres can be fabricated into various physical forms for biomedical applications. It is envisaged to have enormous potential application in the pharmaceutical industry for preparing cost effective collagenous biomaterials useful for medical applications. Moreover, the atelopeptide collagen extracted by this process can be used as a suture material for surgical applications. It may also be molded in diverse shapes, ensuring its use as an ideal carrier, wound cover or drug delivery scaffold, physically cut fibres with any sharp instrument including a sterile scalpel to suit the dimensions of a punctual plug for medical applications. The invention has been applied for patent protection (Indian patent application no. 3133Del2005; Patent pending).

Ophthalmic related
  A process for the preparation of collagen scaffold for ophthalmic applications
The present invention relates to a process for the preparation of collagen scaffold from chrome shavings, a solid waste from tannery, for ophthalmic applications. The process essentially involves treating dechromed shavings with chitosan in presence of plasticizer. The scaffold finds application as corneal implant.
The invention has been applied for patent protection (Indian Patent application no. 920DEL2010).
A process for the preparation of a collagenous film for ophthalmic applications
The present invention relates to a process for the preparation of a collagenous film from a source of fish collagen for ophthalmic applications. The film finds enormous application as corneal implant. Fish scale, which is usually discarded as a waste, finds application in preparing this value added product. The corneal implants prepared through the invention are stable in DMEM and F12 medium up to 21 days and allow growth of limbal corneal cells on its surface.
The invention has been applied for patent protection (Indian Patent application no. 126DEL2010).
A process for the preparation of ionically charged collagen sponge
The process relates to modifying the polar sites of collagen using charged ligands under inert atmosphere to prepare ionically charged collagenous solution, which is cast into sponge of desired shape and size after incorporating foaming agent, crosslinkers and pharmaceutically active components. The resulting collagen sponge is either cationic or anionic at physiological pH and it can be effectively used at the sites of ionic nature. The ionic property of the sponge is of paramount importance in several surgical requirements where charge plays an important role. The ionically charged collagen sponge finds potential application as corneal shields in ophthamological treatment. It may also be used as effective haemostat for wound dressing. It may even be used as bone-cartilage substitute, surgical tampons, laparatomy pads and containers for drug release. The product is capable of entrapping different drugs and the controlled release of entrapped drugs is facilitated. Moreover, the soluble collagen, which is obtained as an intermediate product while making the sponge, finds a very high demand as a component of skin care products such as creams, shampoo etc, in the cosmetic and pharmaceutical industry.
An Indian patent has been granted (Patent no. IN191590) for this invention.

A process for the preparation of viscoelastic, bio-erodible ophthalmic shield.
A process for the preparation of visco-elastic bio-erodible ophthalmic shield is disclosed, whereby pure collagen is obtained from bovine tissues by pH alteration and enzyme treatment this is followed by succinylation with succinic anhydride. The pure succinylated collagen is treated with hydrophilic polymers and antioxidant to get a viscoelastic solution. The solution is dried in moulds in a dust free chamber, cross-linked with UV irradiation and sterilised to get a bio-erodible ophthalmic shield for the treatment of infected eyes, injured eyes, dry eyes and traumatic and non-traumatic eyes. This can include one or more therapeutically active substances that will be released in the eye. The ophthalmic shield is biocompatible, bio-erodible, visco-elastic and transparent which can be used for ophthalmic application. The invention has been applied for Patent protection (Indian Patent application no. 313DEL2004).

A novel bio-erodible insert for ophthalmic applications and a process for the preparation thereof
A novel bio-erodible insert for ophthalmic applications has been developed. The invention further relates to a process for the preparation of the insert. In the said process, collagen is treated with organic polar solvents, hydrophilic polymers and therapeutically active substances under controlled conditions. The resulting solution is air dried in a dust free chamber to make collagen film. This film is cut into shape to obtain insert, which is subjected to cross-linking with UV irradiation followed by conventional sterilization. The resulting insert is very effective for temporary punctual occlusion in various corneal conditions and is very effective for treating dry eye syndrome resulting due to occupational conditions.

The invention has been applied for Patent protection (Indian Patent application no. 2064DEL2006).

A process for the preparation of transparent soft collagen film
A process is provided for the preparation of anionically charged transparent as well as soft collagenous substrate for external application in the medical treatment for eye disease. The process is envisaged to have enormous application in the pharmaceutical industry for preparing ophthalmic substances in the form of films, which can be applied topically to the cornea or instilled in the space between eyeball and lower eyelid for curing eye disease. The ocular region covered with the film can be constantly inspected without disturbing the film as it is very thin and transparent.

The process has been applied for Patent protection (Indian Patent application no. 201DEL2001; Patent pending).
Wound healing
  A process for the preparation of a collagenous biomaterial for medical applications
The present invention relates to a process for the preparation of collagen scaffold from chrome shavings, a solid waste from tannery, for ophthalmic applications. The process essentially involves treating dechromed shavings with chitosan in presence of plasticizer. The scaffold finds application as corneal implant.
The invention has been applied for patent protection (Indian Patent application no. 920DEL2010).
For Further Information Please Contact

Head, Business Processes Division,
CLRI, Adyar, Chennai 600 020.
Tel.:+91 44 2491 5238
email : e-mail :bpdclri@yahoo.com;
bpd@clri.res.in