Claims:
1. Topical composition for treating wound comprising;
a) Mupirocin 2%w/w;
b) Collagen 0.1%w/w to 10%w/w;
c) Pharmaceutically acceptable water soluble ointment base in an amount of 2 to 98% w/w.
2. The composition as claimed in claim 1 wherein the collagen is sourced from an animal selected from Bovine, porcine or from marine source, present preferably in an amount of 0.25% to 5% w/w; more preferably 0.5% to 2.0%w/w and most preferably 1% w/w.
3. The composition as claimed in claim 1, wherein, the pharmaceutically acceptable water soluble ointment base comprising;
a) Polyethylene glycol 400 in an amount of 60 to 70% w/w;
b) Polyethylene glycol 4000 in an amount of 15 to 25% w/w;
c) Propylene glycol in an amount of 5 to 15% w/w; and
d) Poloxamer 407 in an amount of 0.5 to 2% w/w.
4. The composition as claimed in claim 3, wherein, the Propylene glycol acts as a solublising agent for the collagen and also acts as a penetration enhancer for the formulation
5. The composition as claimed in claim 3, wherein, the Poloxamer 407 act as a wetting agent which is essential for drug absorption from the topical systems.
6. The composition as claimed in claim 3, wherein, the Polyethylene glycol acts as a base and also acts as a vehicle for this formulation.
7. The composition as claimed in claim 1, wherein the composition comprises;
S.No Name of the Ingredients %w/w
1 Mupirocin IP/USP 2.00
2 Cogen -S (Bovine Collagen Peptide ) (M/s.New alliance) 1.00
3 Poloxamer 407 ( Kolliphor® P 407) BASF 0.50
4 Polyethylene glycol 400 IH 69.00
5 Polyethylene glycol 4000 IP 17.50
6 Propylene glycol BP 10.00

8. A process for preparation of Mupirocin in ointment base containing collagen, comprising the steps of;
a) heating Polyethylene glycol 4000 at a temperature of about 70°C in a planetary mixer vessel;
b) heating Polyethylene glycol 400 to about 60°C;
c) adding Mupirocin to the step b) under mixing, followed by addition of this Mupirocin solution to the step 1 of planetary mixer;
d) dissolving collagen in part of Propylene glycol with constant stirring and adding Poloxomer 407 followed by gently heating to get a clear solution;
e) adding the solution of step d) to the step c) and mixed in a mixer for 20 minutes to get semi solid gel;
f) filling the gel into suitable tubes and sealed.
9. The process as claimed in claim 8, wherein, the process steps comprises mixing of;
a) Polyethylene glycol 400 in an amount of 60 to 70%;
b) Polyethylene glycol 4000 in an amount of 15 to 25%;
c) Propylene glycol in an amount of 5 to 15%; and
d) Poloxamer 407 in an amount of 0 to 2%.
10. The process as claimed in claim 1 wherein the collagen is sourced from animal selected from Bovine, porcine or from marine source.
, Description:Technical field:
The invention relates to stable topical pharmaceutical composition comprising Mupirocin and collagen (bioactive polymer). More preferably, the invention relates to pharmaceutical composition of Mupirocin and bioactive polymer as wound healing synergiser in ointment formulation and further relates to its method of manufacturing.

Background and prior art of invention
Ulcers can be defined as wounds with a “full thickness depth” and a “slow healing tendency”. Wounds are the leading cause of morbidity and mortality that affect the quality of life of patients, also impose a major burden on the health-care system. Wounds are breaks or openings in the skin of greater than 6 weeks or with frequent recurrence. Venous dysfunction, diabetes mellitus, infections, peripheral neuropathy, pressure, trauma, malignancy, smoking and atherosclerosis are the major pre-disposing factors behind chronic skin ulcers and the lower limb is most commonly affected. Moist skin ulcers provide a favorable environment for bacterial propagation, and diverse microorganisms may be isolated from the ulcers. Colonization and replication of bacteria in the wound site delay the wound healing process. Various methods of treatment of chronic skin ulcers include topical and systemic antibiotics, surgical debridement, skin grafting, compression stockings, and dressings based in the type of wounds.

Every tissue disruption of normal anatomic structure with consecutive loss of function can be described as a wound. Skin wound healing is a dynamic and highly regulated process of cellular, humoral and molecular mechanisms which begins directly after wounding and might last for years.

Integumental injuries are defined as open or outer wounds, whereas inner or closed wounds describe injuries or ruptures of inner organs and tissues with a still intact skin. The closure of a skin wound can be realized by regeneration or repair.
The process of skin wound healing is often described as interplay of cells, growth factors and cytokines ends up in a closure of the skin. However, even when this sensitive balance between cells and mediators might be disrupted, recent data suggest that the deficiency of a cell type or the absence of a mediator can be compensated by others that are involved in wound healing so that the repair can still occur. The process of wound healing can artificially be divided into three to five phases as maintenance of homoeostasis, inflammatory response, proliferative phase, and remodeling which overlap in time and space.

Although topical creams and ointments comprising an active ingredient are widely used, their utility decreases when the composition is required to stay at the site of treatment for a long time. The clinical effect of topical treatments is impaired because compositions are easily removed from the application site due to transpiration, humidity, and erosion, resulting in the need of increasing the daily applications of the composition in the treatment site.

Therefore, bioadhesive and film-forming compositions was proposed in WO199823291, to maintain the active drug at the site of treatment for longer time thereby improving clinical effect of topical compositions and thus patient compliance.

Mupirocin, an antibiotic, is used to treat superficial skin infections such as impetigo or folliculitis as well as other skin infections caused by bacteria. Use of Mupirocin is used as a cream or ointment applied to the affected skin.

There is ample literature available on Mupirocin topical compositions such as ointment and creams.

EP1174133A1 discloses topical compositions comprising amorphous mupirocin calcium, a hydrophobic phase, and hexylene glycol as solvent.

CN102335122B discloses a Mupirocin ointment which comprises the following components in percent by weight: 0.5-5 percent of Mupirocin, 60-89 percent of polyethylene glycol 400, 10-36 percent of Macrogol 4000 and 0.04-0.4 percent of organic acid.

EP2629756 B discloses a pharmaceutical or veterinary anhydrous topical gel composition of Mupirocin or a pharmaceutically or veterinary acceptable salt thereof comprising: a) a lipophilic base selected from the group consisting of petrolatum, medium-chain triglycerides, isopropy myristate and mixtures thereof; b) a bio adhesive selected from the group consisting of polyvinylpyrrolidone and polymethacrylates; and c) a solvent selected from the group consisting of ethanol, propanol, and isopropanol.

Additionally, an article titled, ‘Formulation Development of Mupirocin Adsorbed Collagen Stabilized Silver Nanoparticles to Enhance Synergistic Wound Healing Activity’ published by Veintramuthu Sankar et al in the J. Pharm. Sci. & Res. Vol. 12(4), April 2020, 469-474, discloses the effect of Mupirocin adsorbed collagen stabilized silver nanoparticles.

Another article entitled “Healer granules in non-healing infected wounds”published in Annals of Maxillofacial Surgery, 2018 Jul-Dec; 8(2): 224–229 by Nandimath, et al. discloses collagen particles combined with mupirocin 2% w/w and metronidazole 1% w/w which is effective in managing the space infections associated with extra-oral infected wounds.

Co-Mupimet Collagen Particles and BioFil-AB discloses composition of medicated collagen particles which contains mupiron 2%, metronidazole 1% and collagen for external use against superficial skin infections
A research article titled, “Sol-gel processed mupirocin silica microspheres loaded collagen scaffold: a synergistic bio-composite for wound healing” published in Eur J Pharm Sci. 2014; 52:26-33, by Perumal S, et al. discloses mupirocin-loaded silica microspheres and collagen as a Mu-SM loaded collagen dressing material would be an ideal biomaterial for the treatment of surface wounds, burns and foot ulcers.

US Patent No. 7,732,655 discloses a wound dressing comprising a therapeutic agent (mupirocin); and a barrier layer comprising a substrate (collagen) for initially separating the therapeutic agent from a wound fluid in use.

Indian Patent Application No. 201741028228 (IN385337) discloses collagen-antibiotic particles comprising collagen incorporated with Mupirocin and Metronidazole. The Collagen-antibiotic particles is in the form of powder thereby enabling easily filling up/ dressing up of tunnelled wounds for effecting the process of wound healing.

In the light of the foregoing, there is still a need in the art to provide mupirocin in collagen matrix which can provide effective and speedy re-epithelisation of the external wounds.

Accordingly, it is an objective of the present invention to provide a topical composition comprising Mupirocin incorporated into an ointment matrix which essentially containing collagen that can provide speedier re-epithelisation and healing of external wounds.

Summary of the Invention
In line with the above objective, the present invention provides a topical composition for treating wounds comprising
a) Mupirocin 2%w/w;
b) Collagen 0.1%w/w to 10%w/w; and
c) Pharmaceutically acceptable water soluble ointment base.

Suitable Collagen (Bio active polymer) shall be incorporated in the ointment matrix along with active agent-Mupirocin in an amount of 0.1%w/w to 10w/w; preferably 0.25% to 5% w/w and more preferably 0.5% to 2.0%w/w. The present invention utilizes the speedier re-epithelisation and healing property of combination of Mupirocin and collagen, provided as ointment of Mupirocin in collagen matrix using suitable pharmaceutical ointment base.

Incorporation of skin regeneration bio active component viz., collagen, in ointment matrix allows the infection control agent, viz. Mupirocin to effectively and synergistically control the infection and speedier wound healing process through mechanism such as playing the role of co-factor(s) or by activating dermal enzymes etc.

The present inventors have tested all the available grades of collagen and observed that all grades does not shows synergistic effect when used as collagen matrix for Mupirocin semisolid preparation. However, therapeutic effects of collagen depend on its molecular weight and size (Daltons), ability of forming matrix in semisolid preparation (i.e. in ointment).

The present invention employs Bovine Collagen Peptide (Cogen-S); having a molecular weight of ---- Daltons and a particle size of -----.
The selection of suitable collagen and method of incorporating the same in mupirocin ointment as collagen matrix, synergistically provides speedier re-epithelisation and healing of the wounds.
The present invention further provides process for preparation of the composition which process comprises;
a) heating Polyethylene glycol 4000 at a temperature of about 70°C and transferred to a planetary mixer vessel;
b) heating part of Polyethylene glycol 400 to 60°C;
c) adding Mupirocin to step b) under stirring to step b);
d) adding the solution of step b) to step a) of planetary mixer;
e) dissolving collagen in part of Propylene glycol with constant stirring followed by addition of Poloxamer 407 and heated the solution gently to get a clear solution; and
f) adding the solution of step e) to the step d) followed by mixing and cooling; and
g) filling the ointment obtained ins step f) into ointment tubes.

Detailed description of invention
The present invention provides a topical composition for treating wounds comprising
a) Mupirocin 2%w/w;
b) Collagen 0.1%w/w to 10%w/w; and
c) Pharmaceutically acceptable water soluble ointment base in an amount of 2 to 98%.

Collagen is a major component of the extracellular matrix that plays a key role in each phase of wound healing process due to its chemotactic role. It attracts cells such as fibroblasts and keratinocytes to the wound.

Collagen selection
Hydrolyzed collagen acts in two different forms in the dermis; in the first action, the free amino acids provide building blocks for the formation of collagen and elastin fibers. In the second action, collagen oligopeptides act as ligands, binding to receptors on the fibroblasts’ membrane and stimulating the production of new collagen, elastin, and hyaluronic acid.
Hydrolysed Collagen is widely used in several industries including food, pharmaceutical, cosmetic, biomedical.
Type, source and method of extraction are the main factors that affect collagen properties, such as molecular weight of the peptide chain, solubility, and functional activity.
Method of extraction shall determine the pH of collagen which determines the solubility of the collagen. Pre-treatment conditions, and source of extraction are the main factors that determine final collagen characteristics such as molecular weight, amino acid composition, and molecular structure and biocompatibility.
Solubility and antimicrobial activity depend on type and degree of hydrolysis as well as the type of extraction used in the process. All the above process provides the suitable collagen which is having wound healing property and manufacturing feasibility.

Solubility of Collagen: Solublization is important step in the preparation of collagen ointment matrix. Solubilization of collagen is achieved by using different solvent such polyethyleneglycol and propylene glycol.
The ointment formulation of the present invention comprises the following inactive ingredients, viz., Poloxamer 407, Poly Ethylene Glycol 400 and 4000 and Propylene glycol.
The biocompatible material Bovine collagen was incorporated for improving the synergistic activity of Mupirocin. Poloxamer 407 is used as a wetting agent for this ointment formulation. Poly Ethylene Glycol 400 and 4000 is used as a base/vehicle for this product. The solubility of Bovine collagen is achieved by the addition of propylene glycol. Propylene glycol will increase the penetration efficacy of Mupirocin and collagen.
Accordingly, in a preferred embodiment, the present invention provides topical composition for treating wound comprising;
a) Mupirocin 2%w/w;
b) Collagen 0.1%w/w to 10%w/w;
c) Pharmaceutically acceptable water soluble ointment base in an amount of 2 to 98% w/w.

The source of collagen used in the topical composition of the present invention is an animal source selected from Bovine, porcine or from marine source preferably present in an amount of 0.25% to 5% w/w; more preferably 0.5% to 2.0%w/w and most preferably 1% w/w.

According to the present invention, the pharmaceutically acceptable water soluble ointment base comprising;
a) Polyethylene glycol 400 in an amount of 60 to 70% w/w;
b) Polyethylene glycol 4000 in an amount of 15 to 25% w/w;
c) Propylene glycol in an amount of 5 to 15% w/w; and
d) Poloxamer 407 in an amount of 0.5 to 2% w/w.
The Propylene glycol acts as a solubilizing agent for the collagen and also acts as a penetration enhancer of Mupirocin and collagen. The Poloxamer 407 acts as a wetting agent which is essential for drug absorption from the topical systems.
The Polyethylene glycol acts as a base and also acts as a vehicle for this formulation.

In one of the embodiments, the formulation includes the following active and inactive ingredients as shown below.

S.No Name of the Ingredients %w/w
1 Mupirocin IP/USP 2.00
2 Cogen -S (Bovine Collagen Peptide ) 1.00
3 Poloxamer 407 ( Kolliphor® P 407) BASF 0.50
4 Polyethylene glycol 400 67.20
5 Polyethylene glycol 4000 20.86
6 Propylene glycol BP 8.30

The following steps involved in the manufacturing process.
Step 1 : Polyethylene glycol 4000 was heated at a temperature of about 70°C and transferred to a planetary mixer vessel.
Step 2: Part of Polyethylene glycol 400 was heated to 60°C.
Step 3: To the above step 2, the Mupirocin was added under mixing. This Mupirocin solution was added to the step 1 of planetary mixer.
Step 4: Collagen was dissolved in part of Propylene glycol with constant stirring and Poloxamer 407 was added. This solution was gently heated to get a clear solution.
Step 5. The above solution of step 4 was added to the step 3 and mixed well to get semisolid gel
step 6: The semisolid gel thus obtained was filled into tubes.

Stability report of the ointment composition reveals that the composition is stable for 18 months in long term stability (i.e 25ºCand 60%RH).

A comparative efficacy study has conducted with composition comprising Mupirocin in collagen ointment matrix provided according to the present invention and topical mupirocin, in treatment of chronic skin ulcers at a hospital facility.

Materials and Methods
To prove the efficacy, a randomized, controlled trial was conducted with patients suffering from skin ulcers of Wagner grading 1 or 2 persisting for a period of over 4 weeks. This study was approved by Institutional Ethics Committee of Hycare Super Specialty Hospital in Chennai (Project No: 012/HSSH- EC/2021) and the approved protocol was implemented as per the regulatory guidelines. The subjects were screened based on the inclusion and exclusion criteria as summarized. The protocol was explained in vernacular language to all the subjects in both groups. The patients signed the informed consent and were randomly assigned into control (2 % Mupirocin alone, Leading commercial brand) or test group (Mupimet ointment, viz., 2%Mupirocin combined with 1% collagen), provided according to the example 1 of the present invention whereby the collagen has a molecular weight in range of 3- 6 KDa and particle size is 20 mesh.

50 subjects were recruited in total; 21patients were treated with mupirocin 2% and 24 patients treated with Mupimet ointment. Both the medications were applied topically twice daily for 12 weeks in a quantity sufficient to cover the whole ulcer and up to 1 cm beyond the ulcer edge.

Topical applications were demonstrated initially in the OPD, but subsequent application was unsupervised. Both ointments were dispensed in their original collapsible tube packs. Ulcer area, wound size and wound infection score was ascertained by grading the following parameters- Erythema, Edema, Pain, Exudate and pus. Cumulative Wound Evaluation Score (CWES) and Average Wound Evaluation Sore = (CWES/5)( 0=Absent, 1= Mild, 2= Moderate, 3= Severe). During this study period treatment-emergent adverse reactions were not observed either by the investigators or by the patients. Participants in both the groups were permitted to receive systemic treatment for concomitant diseases provided these were not antimicrobials.

Statistical analysis was done with student’s t test and p value less than 0.05 is considered statistically significant.

Table 1 provides inclusion and exclusion criteria.

Table 1:
INCLUSION CRITERIA
1 Men or women aged between 18 and 65 years
2 Grade 1 or Grade 2 ulcer according to Wagner grading system [ were included in the trial if ulcer duration was more than 4 weeks
3 Subject is able to give written informed consent prior to study start and to comply with the study requirements.

EXCLUSION CRITERIA
1 Known connective tissue or malignant disease.
2 Concomitant treatment with corticosteroids.
3 Immunosuppressive agents, radiation therapy, or anticancer chemotherapy.
4 Topical application of any advanced wound care on this wound (Growth Factor, antiseptics, antibiotics or debriders) within 30 days.
5 Patients with hypersensitivity to gel and collagen.
6 immunocompromising disorders such as HIV/AIDS
7 Patient with cardiovascular disease or intermittent claudication or stroke.
8 Pregnant and Breast feeding women

Results:
Total of 45 subjects participated in the study; 21patients were treated with Mupirocin 2% and 24 patients treated with Mupimet ointment. Table 2 represents Comparison of Demographic features of two groups under study. p value of comparison between two groups is done with t test which shows that there is a statistical significant between the two groups under study. Table 3 shows the grade of ulcer in the test and control group.

Table 2. Comparison of Demographic features of two groups under study
Parameters Test
N=24 Control
N=21 P value
Gender(Percentage) 0.56
Male 20(83.3%) 16(76.2)
Female 4 (16.7%) 5 (23.8)
Age Range 40-79 Range 20-89 0.895
Mean 56.54 56.1
Std Deviation 9.77 12.42
BMI 0.804
Mean 23.74 23.95
Std Deviation 2.64 3.01
p value of comparison between two groups is done with t test which shows that there is a statistical significant between the two groups under study.

Table 3: Ulcer grade based on Wagner Classification
Wagner grade for Ulcer(%) Test Control
Grade 1 17 (70.83) 18 (85.71)
Grade 2 7 (29.16) 3 (14.28)

The results were expressed as mean± standard deviation values to imply the wound size of the foot ulcer from the baseline to the 12 th week. The ulcer size decreased significantly in both arms from baseline to study end (P< 0.05).Table 4 and 5 depicts the t-Test: Two-Sample Assuming Equal Variances in test and control group. Though comparable between the groups at baseline and end of week 12weeks, the ulcer area was significantly reduced in the combined treatment group following 10 weeks of treatment. p value of comparison between two groups is done with t test which shows that there is a statistical significance between the two groups under study.

Table 4: t-Test: Two-Sample Assuming Equal Variances
Test Initial Wound Size Test Wound Size after 10 weeks
Mean 4.32125 1.094166667
Variance 4.461272283 0.402868841
Observations 24 24
Pooled Variance 2.432070562
Hypothesized Mean
Difference 0
df 46
t Stat 7.168242978
P(T<=t) one-tail 2.54964E-09
t Critical one-tail 1.678660414
P(T<=t) two-tail 5.09928E-09
t Critical two-tail 2.012895599

Table 5- t- Test: Two-Sample Assuming Equal Variances
Control Initial wound Size Control wound size after 12weeks
Mean 4.30952381 1.128571429
Variance 5.007904762 0.520142857
Observations 21 21
Pooled Variance 2.76402381
Hypothesized Mean
Difference 0
df 40
t Stat 6.199846362
P(T<=t) one-tail 1.23742E-07
t Critical one-tail 1.683851013
P(T<=t) two-tail 2.47484E-07
t Critical two-tail 2.02107539

As p value is less that 0.05 it is statistically significant that there is a difference between initial wound size and final wound size with respective to control.
Inference: Though both the test value and control value is statistically significant, Test value is highly significant after 10 weeks when compared to Control value of wound size after 12 weeks.

Particularly preferred pharmaceutical compositions of the invention are described in examples below; however the invention is not limited these examples only.
Example 1:

S.No Name of the Ingredients %w/w
1 Mupirocin IP/USP 2.00
2 Cogen -S (Bovine Collagen Peptide ) (M/s.New alliance) 1.00
3 Poloxamer 407 ( Kolliphor® P 407) BASF 0.50
4 Polyethylene glycol 400 IH 69.00
5 Polyethylene glycol 4000 IP 17.50
6 Propylene glycol BP 10.00

The following steps involved in the manufacturing process.
Step 1 : Polyethylene glycol 4000 was heated at a temperature of about 70°C and transferred to a planetary mixer vessel.
Step 2: Part of Polyethylene glycol 400 was heated to 60°C.
Step 3: To the above step 2, the Mupirocin was added under mixing. This Mupirocin solution was added to the step 1 of planetary mixer.
Step 4: Collagen was dissolved in part of Propylene glycol with constant stirring and Poloxamer 407 was added. This solution was gently heated to get a clear solution.
Step 5. The above solution of step 4 was added to the step 3 and mixed well to get semisolid gel
step 6: The semisolid gel thus obtained was filled into tubes.

Example: 2
To formulate Mupirocin ointment with 2% cogen-S
S.No Name of the Ingredients %w/w
1 Mupirocin 2.00
2 Cogen -S (Bovine Collagen Peptide ) 2.00
3 Poloxamer 407 ( Kolliphor® P 407) 1.00
4 Polyethylene glycol 400 70.25
5 Polyethylene glycol 4000 19.75
6 Propylene glycol 5.0

Procedure:
Step 1 : Polyethylene glycol 4000 melted at a temperature of about 70°C
Step 2: Polyethylene glycol 400 was heated to about 60°C
Step 3: To the above step 2, the Mupirocin was added under mixing. This Mupirocin solution was added to the step 1 of planetary mixer.
Step 4: Cogen –S was dissolved in part of Propylene glycol with constant stirring and Poloxamer 407 was added. This solution was gently heated to get a clear solution.
Step 5. The above solution of step 4 was added to the step 3 and mixed in a mixer for 20 minutes to obtain semi solid gel, which is filled in suitable tubes and sealed.
Example: 3
To formulate Mupirocin ointment with 1% cogen S
S.No Name of the Ingredients %w/w
1 Mupirocin 2.00
2 Cogen -S 1.00
3 Poloxamer 407 ( Kolliphor® P 407) 1.00
4 Polyethylene glycol 400 65.25
5 Polyethylene glycol 4000 19.75
6 Propylene glycol BP 10.00
Procedure:

Step 1 : Polyethylene glycol 4000 melted at a temperature of about 70°C
Step 2: Polyethylene glycol 400 was heated to about 60°C
Step 3: To the above step 2, the Mupirocin was added under mixing. This Mupirocin solution was added to the step 1 of planetary mixer.
Step 4: Cogen –S was dissolved in part of PEG400 with constant stirring and
Propylene glycol, Poloxamer 407 was added. This solution was gently heated to get a clear solution.
Step 5. The above solution of step 4 was added to the step 3 and mixed in a mixer for 20 minutes to obtain semi solid gel which is filled in suitable tubes and sealed.

Example: 4
To formulate Mupirocin ointment with 0.5 % of Collagen
S.No Name of the Ingredients %w/w
1 Mupirocin 2.00
2 Cogen -S (Bovine Collagen Peptide ) 0.50
3 Poloxamer 407 ( Kolliphor® P 407) 0.50
4 Polyethylene glycol 400 64.80
5 Polyethylene glycol 3350 22.50
6 Propylene glycol 10.00

Procedure:
Step 1 : Polyethylene glycol 3350 melted at a temperature of about 70°C
Step 2: Polyethylene glycol 400 was heated to about 60°C
Step 3: To the above step 2, the Mupirocin was added under mixing. This Mupirocin solution was added to the step 1 of planetary mixer
Step 4: Cogen –S was dissolved in part of PEG400 with constant stirring and
Propylene glycol, Poloxamer 407 was added. This solution was gently heated to get a clear solution.
Step 5. The above solution of step 4 was added to the step 3 and mixed in a mixer for 20 minutes to obtain semi solid gel which is filled in suitable tubes and sealed.
.
Example: 5

S.No Name of the Ingredients %w/w
1 Mupirocin 2.00
2 Cogen -S (Bovine Collagen Peptide ) 1.00
3 Polyethylene glycol 400 64.50
4 Polyethylene glycol 3350 17.50
5 Propylene glycol 15.00
Procedure:

Step 1 : Polyethylene glycol 3350 was heated at a temperature of about 70°C in a planetory mixer vessel.
Step 2: Polyethylene glycol 400 was heated to about 60°C
Step 3: To the above step 2, the Mupirocin was added under mixing. This Mupirocin solution was added to the step 1 of planetary mixer
Step 4: Cogen –S was dissolved in part of Propylene glycol with constant stirring and Poloxzmer 407 was added. This solution was gently heated to get a clear solution.
Step 5. The above solution of step 4 was added to the step 3 and mixed in a mixer for 20 minutes to obtain semi solid gel which is filled in suitable tubes and sealed.