DESC:“NOVEL TOPICAL PHARMACEUTICAL COMPOSITIONS OF OZENOXACIN”

FIELD OF THE INVENTION:
The present invention relates to novel topical pharmaceutical compositions of Ozenoxacin, preferably in a semisolid form and more specifically a cream form of Ozenoxacin. Further, the present invention discloses the process for preparing the same. The present invention provides an economical and advanced dosage form over existing dosage form.

BACKGROUND OF THE INVENTION:
Ozenoxacin is a quinolone antimicrobial indicated for the topical treatment of impetigo due to Staphylococcus aureus or Streptococcus pyogenes in adult and pediatric patients 2 months of age and older. Structurally, Ozenoxacin is represented as below:

The chemical name of Ozenoxacin is 1-Cyclopropyl-8-methyl-7-(5-methyl-6-methylamino-pyridin-3-yl)-4-oxo1,4-dihydro-quinoline-3-carboxylicacid. Ozenoxacin has a molecular formula of C21H21N3O3.
Ozenoxacin is disclosed in US6335447 and is marketed under the brand name of XEPI® which is in cream form. The dosage and administration directions include applying a thin layer of XEPI® topically to the affected area twice daily for 5 days for topical use only and not for oral, ophthalmic, intranasal, or intravaginal use.
Recently, the increase of community-acquired methicillin-resistant Staphylococcus aureus (MRSA) infections and the emergence of plasmid-mediated mupirocin resistance also in MRSA have been reported.
CA-MRSA spreads within families and close-contact groups or even through public transport, demonstrating transmission cores. Re-infection (including multifocal infection) frequently occurs, if the cores are not sought out and properly eradicated.
In February 2005, the Centers for Infectious Disease Control and Prevention defined CA-MRSA infection as identification of MRSA in a patient with signs and symptoms of infection, either in the outpatient setting or within 48 hours after admission to a hospital. CA-MRSA has increased in countries like US, Europe, Australia and Saudi Arabia in the past 10 years, and CA-MRSA infections in healthy individuals without established risk factors have now been documented in the community. Between January 2005 and March 2008, five (6%) previously healthy children with invasive CA-MRSA infections were identified.
Topical application of antimicrobial agents is a useful tool for therapy of skin and skin structures infections. It has potential advantages compared with systemic therapy which includes avoiding unnecessary exposure of the gut flora which may exert selection for resistance. It has high local drug concentration and negligible systemic absorption with less side effects.
WO2010/043717 discloses a pharmaceutical composition of Ozenoxacin or a pharmaceutically acceptable salt thereof wherein the composition comprises of a suitable carrier which includes one or more emulsifiers selected from mixture of PEG6 stearate, glycol stearate and PEG32 stearate, surfactants as propylene glycol, an oil component which is the Guerbet alcohol 2-octyl dodecanol, low melting point waxes and water dispersible components with non-formaldehyde-donating preservatives. This patent discloses that at room temperature shows 12 months stability study. Hence, there is a need for the pharmaceutical composition which is stable for longer period.
WO2007/015453 discloses lotions comprising Ozenoxacin. This composition comprises use of lower alcohol like ethanol and isopropyl alcohol. In addition, this composition also includes water soluble polymers like hydroxyethyl cellulose. This composition further comprises polyhydric alcohol. The final pH of the composition is between 9 to 12. This patent has reported 13 weeks stability data. Hence, it may be concluded that there is a need for the stable composition of Ozenoxacin.
Ozenoxacin formulations available currently in the market are formulated specifically with the excipients as benzoic acid, octyldodecanol, peglicol 5 oleate, pegoxol 7 stearate, propylene glycol, purified water, stearyl alcohol. As per the clinical trials data, the inventors of the present invention have noted that the marketed composition produced adverse reactions like rosacea and seborrheic dermatitis. Therefore, the inventors of the present invention believe that there is an unmet need for more stable pharmaceutical composition of Ozenoxacin which produces lesser side effects.
Semisolid topical compositions are useful because of their better manipulation and consequent patient preferences. However, in spite of the great diversity of components present in the semisolid compositions disclosed in the art, no quantitative studies are available for them. Thus, there is a need of a semisolid topical compositions comprising Ozenoxacin as an active ingredient, wherein microbiological and therapeutic activity are higher with more stable and durability.

OBJECT OF THE INVENTION:
It has been noted that a number of limitations or problems in the prior-art as well as marketed formulation which includes lesser stability, more side effects and costly composition. The inventors of the present invention have developed novel pharmaceutical compositions of Ozenoxacin which fulfills all limitations by providing a workable solution to above problems. Objects of the invention of the present invention are as followed:
The primary object of the present invention is to provide a novel topical semisolid pharmaceutical composition of Ozenoxacin in cream form.
Another object of the present invention is to provide the topical semisolid pharmaceutical composition of Ozenoxacin with novel excipients.
One more objective of the present invention is to provide the topical composition which is free from wax, hence reducing stickiness in the cream and thereby increasing patient compliance.
Another object of the present invention is to provide an economical and advanced dosage form over existing dosage form and with less side effects and enhanced microbiological and therapeutic activity with durability.
Yet another object of the present invention is to provide a pharmaceutical composition of Ozenoxacin having excellent assay and higher stability with novel excipients.
Yet another object of the present invention is to provide a novel process for preparation of topical semisolid dosage form of Ozenoxacin in cream form.
Still another object of the present invention is to provide a pharmaceutical composition comprising Ozenoxacin for the use in treatment of CS-MRSA.
Another object of the present invention is to provide process for the preparation of pharmaceutical composition comprising Ozenoxacin with novel excipients, which then was formulated into a topical semisolid cream formulation, wherein desired stability of Ozenoxacin is obtained.

SUMMARY OF THE INVENTION:
Despite of extensive research on Ozenoxacin as reported in prior-art publications, there is an unmet need to develop a patient compliant Ozenoxacin cream with technical advancement which provide good stability for long-term storage at an affordable price. Thus, the present invention has solved the problem that is present in the prior-arts as well as in the existing marketed formulations.
The present invention discloses a novel topical pharmaceutical composition of Ozenoxacin preferably in cream form with pharmaceutically acceptable novel excipients and method of preparation thereof. The pharmaceutical composition of present invention comprises Ozenoxacin with one or more pharmaceutically acceptable excipients selected from the group comprising of at least one emulsifier, surfactant, preservative or stabilizer, thickening agent, emollient and oil component.
The novel topical pharmaceutical composition according to the present invention is economical and advanced dosage form over existing dosage form, with less side effects and time efficient, especially for large-scale production, whereby the pharmaceutical composition shows a desired stability and higher stability with the said excipients.
One embodiment of the novel semisolid pharmaceutical composition of Ozenoxacin as per the present invention is devoid of wax. Due to absence of wax, the sticky nature of the cream is avoided. Instead of using of wax, the inventors of the present invention have used emollient which has soothing properties to skin and does not make the cream formulation in sticky nature. Therefore, this technical advancement results in to better patient compliance.
Another embodiment of the novel semisolid pharmaceutical composition of Ozenoxacin as per the present invention is of using new excipient namely Sepineo P600. This excipient not only work as thickening agent but also work as emollient as well as stabilizer in certain concentrations. Therefore, due to presence of this unique novel excipient, the present invention has become novel and property of this novel excipient prove that the present invention is not only mere admixture; however, it is actually a synergistic composition, which overcome the prior-art publications as well as marketed formulations.
The details of one or more embodiments of the invention are set forth in the description below. Other features of the invention will be apparent from the description.

DETAILED DESCRIPTION OF THE INVENTION:
The nature of the invention is clearly described in the specification. The invention has various components and they are clearly described in the specification. The present invention will now be disclosed by describing certain preferred and optional embodiments, to facilitate various aspects thereof.
References to “an”, “one”, or “various” embodiments in this disclosure are not necessarily to the same embodiment, and such references contemplate more than one embodiment. The following detailed description is, therefore, not to be taken in a limiting sense, and the scope is defined only by the appended claims, along with the full scope of legal equivalents to which such claims are entitled.
In accordance with the present invention, a novel topical pharmaceutical composition comprising Ozenoxacin as an active ingredient and one or more excipients comprising of at least emulsifier, surfactant, preservative, thickening agent and emollients and oil component. This composition surprisingly devoid of wax.
The present invention discloses a novel topical pharmaceutical composition of Ozenoxacin thereof preferably in a cream form.
Surfactants a may include in the present invention but are not limited to one or more from the group comprising of sorbitan oleate monoolein/propylene glycol, Ca/C10 fatty acid mono- and diglycerides from coconut oil, soy lecithin, egg phosphatides, citric acid esters of monoglycerides, lactic acid esters of monoglycerides, diacetyl tartaric acid esters of monoglycerides, succinic acid esters of monoglycerides, sucrose fatty acid esters and polysorbate 80.
Emulsifiers may include in the present invention but are not limited to one or more from the group comprising of ethylene glycol monostearate, sorbitan tristearate, and more preferably sorbitan monostearate.
Water dispersible components may include in the present invention but are not limited to one or more from the group comprising of polyethylene glycol 400, hexylene glycol, propylene glycol, polypropylene glycol-10 methylglucose ether, ethoxydiglycol, polyethylene glycol-6 caprylic/capric glyceride, ethylene glycol monobutyl ether, Preferably, the water dispersible component is propylene glycol.
Non-formaldehyde-donating preservatives may include in the present invention but are not limited to one or more from the group comprising of ammonium benzoate, ammonium propionate, benzisothiazolinone, benzoic acid, benzotriazole, benzyl alcohol, benzylparaben, 5-bromo-5-nitro-1,3-dioxane, 2-bromo-2-nitropropane-1,3-diol, butyl benzoate, butylparaben, calcium benzoate, calcium paraben, calcium propionate, calcium salicylate, calcium sorbate, chlorhexidine diacetate, chlorhexidine digluconate, chlorhexidine dihydrochloride. Preferably, the preservative used is benzoic acid as per this present invention.
Oil components or also called as emollient may include in the present invention but are not limited to one or more from the group comprising of Garbed alcohols based on fatty alcohols containing 8 to 10 carbon atoms, esters of linear C6-22 fatty acids with linear or branched C6-22 fatty alcohols, esters of branched C6-13 carboxylic acids with linear or branched C6-22 fatty alcohols, esters of linear C6-22 fatty acids. Preferably, the oil component is selected as per the present invention is 2- Octyl dodecanol, light liquid paraffin.
Thickening agent may include in the present invention but are not limited to “Sepineo P600”. This polymer also acts as stabilizer as well as emollient based on the concentration of the same in the final composition. Sepineo P600 is liquid inverse emulsion polymer of Acrylamide / Sodium Acryloyldimethyl Taurate Copolymer / Isohexadecane & Polysorbate 80. In addition, the skin easily tolerates the said novel excipient, hence, it is very much useful in topical formulation of the present invention.
Penetration enhancer may include in the present invention but are not limited to Isopropyl Myristate.
Further, to the above excipients, the present invention also contains water as main base. Water may include in the present invention but are not limited to purified water or distilled water.
Accordingly, the present invention provides the use of ointments and creams of the present invention in the treatment or prevention of skin and skin structure infections, being non- limitative examples of such skin and skin structure infections impetigo, foliculitis, forunculosis, acne, secondarily-infected traumatic lesions, overinfected dermatoses, and secondarily-infected burns, and those skin and skin structure infections caused by methicillin-susceptible Staphylococcus aureus (MSSA), methicillin-resistant Staphylococcus aureus (MRSA) including ciprofloxacin-resistant strains, methicillin-susceptible Staphylococcus epidermidis (MSSE), methicillin-resistant Staphylococcus epidermidis (MRSE), Streptococcus pyogenes, and Group G Streptococci.
Another object of the present invention is the use of new compositions in the treatment or prevention of sexually transmitted diseases and genital tract infections in a human or an animal. Accordingly, the present invention provides the use of ointments and creams of the present invention in the treatment or prevention of sexually transmitted diseases and genital tract infections, such as those caused by Streptococcus agalactiae group B, Neisseria gonorrhoeae, Chlamydia trachomatis, Mycoplasma hominis, and Ureaplasma urealyticum.
Another object of the present invention is the use of new compositions in the eradication of nasopharynx infections in asymptomatic nasal carriers in a human or an animal. Accordingly, the present invention provides the use of ointments and creams of the present invention in the eradication of nasopharynx infections in asymptomatic nasal carriers, the infections being caused by methicillin-susceptible Staphylococcus aureus (MSSA), methicillin- resistant Staphylococcus aureus (MRSA) including ciprofloxacin-resistant strains, penicillin- resistant Streptococcus pneumoniae, Beta-lactamase positive Haemophilus influenzae, non- typeable strains of Haemophilus influenzae, Beta-lactamase positive Moraxella catarrhalis, Neisseria meningitides, Legionella pneumophila, Mycoplasma pneumoniae, Legionella pneumophila, and Mycobacterium tuberculosis.
The compositions of the present invention may be used by direct application to the affected or to protect skin or genital area. Also the compositions may be used by administration to the nasal cavity, preferably to the nasopharynx, in particular the anterior nasopharynx.
Also, the compositions of the present invention may be used in the treatment of skin and skin structure infections, sexually transmitted diseases and genital tract infections, and in the eradication of nasopharynx infections in asymptomatic nasal carriers when such infections are resistant to usual topical antibiotics, being such antibiotics mupirocin, fusidic acid, retapamulin, and quinolone compounds, i.e. nadifloxacin.
Another object of the present invention is to provide novel methods to treat or prevent skin and skin structure infections in a human or an animal in need by administering the compositions of the present invention.
Another object of the present invention is to provide novel methods to treat or prevent sexually transmitted diseases and genital tract infections in a human or an animal in need by administering the compositions of the present invention. Another object of the present invention is to provide novel methods for the eradication of nasopharynx infections in asymptomatic nasal carriers in a human or an animal in need by administering the compositions of the present invention.
The compositions according to the invention can be used effectively and safely without clinically significant dermatological or systemic related adverse events, because of the skin absorption of Ozenoxacin is negligible.
Throughout the description and claims the word "comprise" and variations of the word, such as "comprising", are not intended to exclude other technical features, additives, components, or steps. Additional objects, advantages and features of the invention will become apparent to those skilled in the art upon examination of the description or may be learned by practice of the invention. The following examples are provided by way of illustration, and are not intended to be limiting of the present invention.

GENERAL EXAMPLES:
TABLE-1: General composition for Ozenoxacin cream:
Ingredients % W/W UPTO
Phase A: Oil Phase
Surfactant / Emulsifier 4.50
Oil component 8.00
Emollient 4.00
Ozenoxacin 1.00
Weight of Oil Phase 17.50
Phase B: Aqueous Phase
Preservative 0.10
Thickening Agent 2.00
Stabilizer 2.00
Water dispersible components 21.00
Aqueous Base 59.40
Weight of Aqueous Phase 82.50
Total Weight 100.00

In one embodiment of the present invention, above general formula of Table-1 was used to prepare the composition. These compositions also shown longer stability than the existing pharmaceutical composition.
In another embodiment of the present invention, below general formula of Table-2 was used to prepare the composition. This composition used has also shown longer stability than the existing pharmaceutical composition.

TABLE-2: General composition for Ozenoxacin cream:
Ingredients % W/W UP TO
Phase A: Oil Phase
Surfactant / Emulsifier 8.00
Oil component 2.00
Emollient 20.00
Ozenoxacin 1.00
Weight of Oil Phase 31.00
Phase B: Aqueous Phase
Surfactant / Emulsifier 0.50
Preservative 0.10
Thickening Agent 3.00
Stabilizer 3.00
Water dispersible components 21.00
Aqueous Base 44.40
Weight of Aqueous Phase 69.00
Total Weight 100.00

Inventors of the present invention provides a novel topical pharmaceutical composition of Ozenoxacin which would be considered as patient compliant due its better stability which ultimately leads to enhanced bioavailability.

General Method of Manufacturing:
The present invention also discloses a method of manufacturing of novel topical pharmaceutical composition of Ozenoxacin in cream form.
The process of the present invention is divided in different following steps as below:

The present invention can be described by way of example or strategy only. It is to be recognized that modifications falling within the scope and spirit of the description or claims, which would be obvious to a person skilled in the art based upon the disclosure herein, are also considered to be included within the scope of this disclosure.

WORKING EXAMPLES:
EXAMPLE-1:
TABLE-3
Ingredients % W/W
Phase A: Oil Phase
Polysorbate 60 3.50
2-Octyl dodecanol 8.00
Sorbitan Monostearate 1.00
Light Liquid Paraffin 4.00
Ozenoxacin 1.00
Weight of Oil Phase 17.50
Phase B: Aqueous Phase
Benzoic Acid 0.10
Sepineo P600 2.00
Propylene Glycol 21.00
Purified Water 59.40
Weight of Aqueous Phase 82.50
Total Weight 100.00

Stepwise Manufacturing process for Example-1:
1. Preparation of Oil Phase A:
i. Isopropyl Myristate and Light Liquid Paraffin were taken in a Oil Phase tank;
ii. 2- Octyl dodecanol, Polysorbate 60 & Sorbitan Monostearate were added in Oil Phase tank one by one;
iii. all the ingredients were mixed at 65-85oC until system become clear.

2. Preparation of Water Phase B:
i. Approx. 80% of purified water of total qty. was taken into jacketed PLM and was heated at a temperature between 65-85oC. (Keep aside approx. 20% of purified water for rinsing of Sepineo P600 container/bag);
ii. Benzoic Acid and Propylene glycol were added to the above jacketed PLM containing water one by one with stirring;
iii. all the ingredients were mixed at 65-85oC until clear system is obtained.

3. Homogenization:
i. homogenizer was started in PLM and transfer oil phase through 100# filtration in jacketed PLM already having water phase by vacuum pump at a pressure between 0 to -30 Inch/Hg. Oil Phase tank was rinsed with remaining qty of Light Liquid Paraffin (approx. 35% of total qty) and temperature was maintained at 65-85°C during mixing;
ii. above system was mixed by homogenizer for 30 minutes followed by running of mixer/scrapper at slow speed;
iii. the homogenizer was stopped after 30 minutes and cooling performed up to 50-60°C with mixing by circulating cool water into jacketed wall of PLM.

4. After achieving temperature at 50-60°C temperature, Sepineo P600 was added into jacketed PLM was continue to mix at medium speed of mixer with cooling process upto 25-32°C until observation confirmation of cream.

EXAMPLE-2:
TABLE-4
Ingredients % W/W
Phase A: Oil Phase
Polysorbate 60 3.00
2-Octyl dodecanol 2.00
Sorbitan Monostearate 5.00
Light Liquid Paraffin
15.00
Isopropyl Myristate 5.00
Ozenoxacin 1.00
Weight of Oil Phase 31.00
Phase B: Aqueous Phase
Polysorbate 60 0.50
Benzoic Acid 0.10
Sepineo P600 3.00
Propylene Glycol 21.00
Purified Water 44.40
Weight of Aqueous Phase 69.00
Total Weight 100.00

Stepwise Manufacturing process for Example-2:
1. Preparation of Oil Phase A:
i. Isopropyl Myristate and Light Liquid Paraffin were taken in an Oil Phase tank;
ii. 2- Octyl dodecanol, Polysorbate 60 & Sorbitan Monostearate were added in Oil Phase tank one by one;
iii. all the ingredients were mixed at 65-85oC until system become clear.

2. Preparation of Water Phase B:
iv. Approx. 80% of purified water of total qty. was taken into jacketed PLM and was heated at a temperature between 65-85oC. (Keep aside approx. 20% of purified water for rinsing of Sepineo P600 container/bag);
v. Polysorbate 60, Benzoic Acid and Propylene glycol were added to the above jacketed PLM containing water one by one with stirring;
vi. all the ingredients were mixed at 65-85oC until clear system is obtained.

3. Homogenization:
vii. homogenizer was started in PLM and transfer oil phase through 100# filtration in jacketed PLM already having water phase by vacuum pump at a pressure between 0 to -30 Inch/Hg. Oil Phase tank was rinsed with remaining qty of Light Liquid Paraffin (approx. 35% of total qty) and temperature was maintained at 65-85°C during mixing;
viii. above system was mixed by homogenizer for 30 minutes followed by running of mixer/scrapper at slow speed;
ix. the homogenizer was stopped after 30 minutes and cooling performed up to 50-60°C with mixing by circulating cool water into jacketed wall of PLM.

4. After achieving temperature at 50-60°C temperature, Sepineo P600 was added into jacketed PLM was continue to mix at medium speed of mixer with cooling process upto 25-32°C until observation confirmation of cream.

EXAMPLE-3:
TABLE-5
Ingredients % W/W
Phase A: Oil Phase
Polysorbate 60 3.50
2-Octyl dodecanol 2.00
Sorbitan Monostearate 5.00
Light Liquid Paraffin
15.00
Isopropyl Myristate 5.00
Ozenoxacin 1.00
Weight of Oil Phase 31.00
Phase B: Aqueous Phase
Benzoic Acid 0.10
Sepineo P600 4.00
Propylene Glycol 21.00
Purified Water 43.40
Weight of Aqueous Phase 68.50
Total Weight 100.00

Stepwise Manufacturing process for Example-3:
1. Preparation of Oil Phase A:
x. Isopropyl Myristate and Light Liquid Paraffin were taken in a Oil Phase tank;
xi. 2- Octyl dodecanol, Polysorbate 60 & Sorbitan Monostearate were added in Oil Phase tank one by one;
xii. all the ingredients were mixed at 65-85oC until system become clear.

2. Preparation of Water Phase B:
xiii. Approx. 80% of purified water of total qty. was taken into jacketed PLM and was heated at a temperature between 65-85oC. (Keep aside approx. 20% of purified water for rinsing of Sepineo P600 container/bag);
xiv. Benzoic Acid and Propylene glycol were added to the above jacketed PLM containing water one by one with stirring;
xv. all the ingredients were mixed at 65-85oC until clear system is obtained.

3. Homogenization:
xvi. homogenizer was started in PLM and transfer oil phase through 100# filtration in jacketed PLM already having water phase by vacuum pump at a pressure between 0 to -30 Inch/Hg. Oil Phase tank was rinsed with remaining qty of Light Liquid Paraffin (approx. 35% of total qty) and temperature was maintained at 65-85°C during mixing;
xvii. above system was mixed by homogenizer for 30 minutes followed by running of mixer/scrapper at slow speed;
xviii. the homogenizer was stopped after 30 minutes and cooling performed up to 50-60°C with mixing by circulating cool water into jacketed wall of PLM.

4. After achieving temperature at 50-60°C temperature, Sepineo P600 was added into jacketed PLM was continue to mix at medium speed of mixer with cooling process upto 25-32°C until observation confirmation of cream.

TEST EXAMPLE-1: STABILITY STUDY TESTING
The formulation prepared as per the example-2 of the present invention was placed for stability testing study. The samples of example-2 were placed in 40°C and 75% RH for six months and following results are obtained.
Parameters Initial After 1 month After 3 months After 6 months
Example-2
% Assay 101.00% 101.00% 102.44% 102.00%
pH 4.68 4.67 4.69 4.68
% Total Impurities 0.436% 0.409% 0.432% 0.210%

From above data, the inventors of the present invention surprisingly found that Ozenoxacin formulations prepared as per the preset invention are stable even after six months of stability testing.
The inventors of the present invention surprisingly found from the above data that the present invention shown consistency in % assay proving it a stable dosage form in long term storage as well. Thus, the final product of the present invention is found as stable due to its unique composition which is not just a mere admixture but provides synergistic effect.
It was surprisingly found by the inventors of the present invention that in example-1, when there is very low concentration of Sepineo P600, the composition prepared was very less viscous. Viscosity is the main external feature of any semisolid dosage form including cream.
Another surprising effect was found when the inventors of the present invention slightly increased the concentration of Sepineo P600 to increase the viscosity. As noted in example-3, a slight increase in Sepineo P600 lead to increase the viscosity of the final composition at very high level where one can feel difficulty to take out the cream from the container.
Therefore, at last, the inventors of the present invention, after a series of experiments came to the conclusion that optimum quantity of Sepineo P600 is required to obtain the cream with proper consistency. Thus, this excipient helped the inventors of the present invention to develop a technically advanced dosage form over the prior-art publications.
In addition, the inventors of the present invention surprisingly developed a formulation which is devoid of wax. Wax is generally costly in nature and hence, the inventors of the present invention replaced the high quantity of wax with other excipients to reduce the final composition price. Hence, the formulations as per the present invention are having economic significance, as well.
Further, the inventors of the present invention have also previously described that how the present invention is novel, inventive and containing an industrial applicability. Therefore, the inventors of the present invention have been successful in developing an invention within the scope of the Patents Act, 1970.
The invention described herein comprises in various objects as mentioned above and their description in relation to characteristics, compositions and process adopted. While these aspects are emphasised in the invention, any variations of the invention described above are not to be regarded as departure from the spirit and scope of the invention as described.

,CLAIMS:We claim:
1. A novel semisolid stable composition of Ozenoxacin comprising of:
(a) at least one thickening agent wherein the thickening agent is Sepineo P600;
(b) at least one surfactant wherein the surfactant is polysorbate 80;
(c) at least one skin penetration enhancer wherein the skin penetrator is isopropyl myristate;
wherein individually (a), (b) and (c) are in the concentration of not more than 5% w/w of the total composition.

2. The novel semisolid stable composition of Ozenoxacin as claimed in claim 1, further comprising of at least one emollient wherein the emollient is selected from light liquid paraffin, 2-octyl dodecenol or mixture thereof in the combined concentration not less than 15% w/w of the composition.

3. The novel semisolid stable composition of Ozenoxacin as claimed in claim 1, further comprising of at least one emulsifier wherein the emulsifier is selected from Sorbitan monostearate in the concentration not more than 5% w/w of the composition.

4. The novel semisolid stable composition of Ozenoxacin as claimed in claim 1, further comprising of at least one water dispersible compound wherein the water dispersible compound is selected from propylene glycol, methylglucose ether, ethoxydiglycol, polyethylene glycol-6 caprylic/capric glyceride, ethylene glycol monobutyl ether or mixture thereof in the combined concentration not less than 20% w/w of the composition.

5. The novel semisolid stable composition of Ozenoxacin as claimed in claim 4, wherein at least one water dispersible compound is propylene glycol in the concentration not less than 20% w/w of the composition.

6. The novel semisolid stable composition of Ozenoxacin as claimed in claim 1, further comprising of at least one preservative wherein the preservative is benzoic acid.

7. The novel semisolid stable composition of Ozenoxacin as claimed in claim 1, wherein the semisolid composition is in the form of cream.

8. The novel semisolid stable composition of Ozenoxacin as claimed in claim 7, wherein the semisolid composition is in the form of cream having pH not more than 5.

9. The novel semisolid stable composition of Ozenoxacin comprising of following formula:
Ingredients % W/W
Ozenoxacin 1.00
Sepineo P600 3.00
Polysorbate 60 3.50
Isopropyl Myristate 5.00
Sorbitan Monostearate 5.00
Light Liquid Paraffin 15.00
2-Octyl dodecanol 2.00
Benzoic Acid 0.10
Propylene Glycol 21.00
Purified Water Q.S.

10. A process for preparation of novel semisolid stable composition of Ozenoxacin comprising of following steps:
(a) preparing oil phase by mixing Isopropyl Myristate and Light Liquid Paraffin followed by addition of 2- Octyl dodecanol, Polysorbate 60 & Sorbitan Monostearate;
(b) preparing water phase by dissolving Sepineo P600 in water and followed by addition of Polysorbate 60, Benzoic Acid and Propylene glycol;
(c) homogenizing oil phase obtained in step-a with water phase in step-b to get the homogenized solution which upon cooling prepares cream.