Abstract: STABLE AND SENSORIALLY SUPERIOR TOPICAL FORMULATION The instant disclosure provides a stable and sensorially superior (non-patchy, non oily/greasy, easily spreadable etc.) topical preparation with zinc oxide and boric acid as skin beneficiary actives in the form of emulsion with the combination of thickeners, humectants, oil components (hydrocarbons, emollients, bodying agents) and non-ionic emulsification system at a particular concentration. The present disclosure also relates to a process of preparation stable topical formulation.
Claims:1. A stable topical formulation comprising:
a) zinc oxide;
b) boric acid;
c) steareth 21;
d) steareth 2;
e) at least one non-ionic thickener;
f) at least one silicone; and
g) at least one oil component,
wherein the steareth 21 to the steareth 2 weight ratio is in the range of 1:0.3-1:3.
2. The formulation as claimed in claim 1, wherein the silicone is selected from the group consisting of dimethicone, polysilicone-11, phenyl trimethicone, trimethylsilylamodimethicone, stearoxytrimethylsilane, cyclomethicone, hexamethyldisiloxane, octamethyltrisiloxane, decamethylpentacyclosiloxane, dialkenylsilicones, dialkylsilicones, diaryl silicones, alkylarylsilicones, alkenylalkylsilicones, and mixtures thereof.
3. The formulation as claimed in claim 2, wherein the silicone is dimethicone.
4. The formulation as claimed in claim 1, wherein the oil component comprises at least one hydrocarbon, at least one emollient, and combinations thereof.
5. The formulation as claimed in claim 4, wherein the hydrocarbon is selected from the group consisting of petrolatum, paraffin wax, mineral oil, and combinations thereof.
6. The formulation as claimed in claim 4, wherein the emollient is selected from the group consisting of squalene, cyclopentasiloxane, dimethicone, derivatives, isopropyl myristate, isopropyl palmitate, isopropyl isostearate, C12-15 alkyl benzoate, fatty alcohols, and combinations thereof.
7. The formulation as claimed in claim 1, wherein the non-ionic thickener is selected from the group consisting of xanthan gum, guar gum, gum arabic, and combinations thereof.
8. The formulation as claimed in claim 7, wherein the non-ionic thickener is xanthan gum.
9. The formulation as claimed in claim 1, wherein the formulation has a pH in the range of 7.0-8.0.
10. A stable topical formulation comprising:
a) zinc oxide having a weight percentage in the range of 0.5-3% with respect to the formulation;
b) boric acid having a weight percentage in the range of 0.5-5% with respect to the formulation;
c) steareth 21 having a weight percentage in the range of 0.9-2.7% with respect to the formulation;
d) steareth 2 having a weight percentage in the range of 0.9-2.7% with respect to the formulation;
e) at least one non-ionic thickener having a weight percentage in the range of 0.5-0.75% with respect to the formulation;
f) at least one silicone having a weight percentage in the range of 2-3% with respect to the formulation; and
g) at least one oil component having a weight percentage in the range of 20-30% with respect to the formulation,
wherein the steareth 21 to the steareth 2 weight ratio is in the range of 1:0.3-1:3.
11. A process for the preparation of a stable topical formulation as claimed in claim 1, comprising steps of:
a) contacting at least one non-ionic thickener and water to obtain water phase;
b) contacting at least one oil component with steareth 21 and steareth 2 to obtain oil phase;
c) contacting the water phase and the oil phase followed by homogenization to obtain a first mixture; and
d) contacting zinc oxide and boric acid with first mixture to obtain stable topical formulation,
wherein steareth 21 to steareth 2 weight ratio is in the range of 1:0.3-1:3.
12. The process as claimed in claim 11, comprising steps of:
a) contacting at least one non-ionic thickener and water to obtain a dispersion, followed by heating the dispersion till the dispersion attains a a temperature in the range of 70 - 75 °C to obtain a water phase;
b) contacting at least one oil component with steareth 21 and steareth 2 followed by heating the mixture at a temperature in the range of 70-75 0C to an obtain oil phase;
c) contacting the water phase and the oil phase at a temperature in the range of 70-75 0C followed by homogenization for a period in the range of 5-30 minutes at a stirring speed in the range of 5000-7000 rpm to obtain a first mixture; and
d) contacting zinc oxide and boric acid with the first mixture, followed by stirring at a speed in the range of 70-75 rpm at a temperature in the range of 25-30 0C to obtain stable topical formulation.
, Description:As Attached
| # | Name | Date |
|---|---|---|
| 1 | Form 5 [24-01-2017(online)].pdf | 2017-01-24 |
| 2 | Form 3 [24-01-2017(online)].pdf | 2017-01-24 |
| 3 | Description(Complete) [24-01-2017(online)].pdf_321.pdf | 2017-01-24 |
| 4 | Description(Complete) [24-01-2017(online)].pdf | 2017-01-24 |
| 5 | Other Patent Document [20-03-2017(online)].pdf | 2017-03-20 |
| 6 | Form 26 [20-03-2017(online)].pdf | 2017-03-20 |
| 7 | Correspondence by Agent_Proof of Right-Form1_22-03-2017.pdf | 2017-03-22 |
| 8 | Correspondence by Agent_Power of Authorisation_22-03-2017.pdf | 2017-03-22 |
| 9 | 201741002765-FORM 18 [19-01-2021(online)].pdf | 2021-01-19 |
| 10 | 201741002765-Response to office action [20-09-2021(online)].pdf | 2021-09-20 |
| 11 | 201741002765-FER.pdf | 2021-10-17 |
| 12 | 201741002765-OTHERS [05-05-2022(online)].pdf | 2022-05-05 |
| 13 | 201741002765-FORM 3 [05-05-2022(online)].pdf | 2022-05-05 |
| 14 | 201741002765-FER_SER_REPLY [05-05-2022(online)].pdf | 2022-05-05 |
| 15 | 201741002765-PatentCertificate09-09-2022.pdf | 2022-09-09 |
| 16 | 201741002765-IntimationOfGrant09-09-2022.pdf | 2022-09-09 |
| 1 | SearchreportE_22-03-2021.pdf |