5 August 2010 ( ) WO 2010/ A2

Transcription

1 (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (43) International Publication Date (10) International Publication Number 5 August 2010 ( ) WO 2010/ A2 (51) International Patent Classification: (74) Agent: BABU, M.R., Ramesh; M/s Lex Orbis (Intellec A61K 36/8965 ( ) tual Property Practice), 709/710, Tolstoy House, (21) International Application Number: Tolstoy Marg, New Delhi (IN). PCT/IB2010/ (81) Designated States (unless otherwise indicated, for every kind of national protection available): AE, AG, AL, AM, (22) International Filing Date: AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, 30 January 2010 ( ) CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO, (25) Filing Language: English DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, (26) Publication Language: English HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, (30) Priority Data: ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, 200/DEL/ January 2009 ( ) IN NO, NZ, OM, PE, PG, PH, PL, PT, RO, RS, RU, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, (71) Applicant (for all designated States except US): HI TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. MALAYA GLOBAL HOLDINGS LIMITED; Eliza bethan Square, Block B, P.O. Box 1162, Grand Cayman (84) Designated States (unless otherwise indicated, for every KYl-1 102, Cayman Islands, Bristish West Indies (KY). kind of regional protection available): ARIPO (BW, GH, GM, KE, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, ZM, (72) Inventors; and ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, (75) Inventors/Applicants (for US only): SURIA- TM), European (AT, BE, BG, CH, CY, CZ, DE, DK, EE, NARAYANAN, Ramesh [IN/IN]; Research and Devel ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, opment Center, The Himalaya Drug Company, Makali, MC, MK, MT, NL, NO, PL, PT, RO, SE, SI, SK, SM, Bangalore , Karnataka (IN). BABU, Uddagiri, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, Venkanna [IN/IN]; Research and Development Center, ML, MR, NE, SN, TD, TG). The Himalaya Drug Company, Makali, Bangalore , Karnataka (IN). MAHENDRA, Chandrika [IN/IN]; Published: Research and Development Center, The Himalaya Drug without international search report and to be republished Company, Makali, Bangalore , Karnataka (IN). upon receipt of that report (Rule 48.2(g)) (54) Title: HERBAL CREAM AND LOTION COMPOSITIONS AND METHODS OF PREPARATION THEREOF (57) Abstract: Disclosed here a herbal cream or lotion composition comprising extracts of organically certified herbs organic es sential oils along with pharmaceutically acceptable excipients, wherein the extract is prepared employing a super critical fluid ex traction or water extraction.

2 HERBAL CREAM AND LOTION COMPOSITIONS AND METHODS OF PREPARATION THEREOF Field of the Invention This invention in general relates to a herbal body cream and lotion composition and methods of preparation thereof. In particular, the present invention provides a herbal cream or lotion composition comprising extracts of organically excipients, wherein the extract is prepared employing a super critical fluid extraction or water extraction. Background of the Invention Body cream and lotions generally contain ingredients like liquid paraffin that is petroleum based, and ethoxylated emulsifiers that are made using ethylene oxide and extract of herbs in case of herbal products that are grown by regular methods using pesticides and using harsh preservatives. The use of ethoxylated emulsifiers, however, is seen more and more as a disadvantage. Now-a-days consumers increasingly prefer natural ingredients in cosmetics, which are free from chemical and other impurities and are safe to use. It is therefore an important aspect to develop a herbal cream and lotion composition that is made of natural ingredients to provide better moisturising effect and is safe to use. Related Art US Patent no by Bindra et al. discloses a herbal cream composition. The composition comprising natural wax as an emulsifier, extract of Curcuma and the gum of Acacia or Colohonium or shorea. This is combined with essential oil and petroleum jelly. US Patent no by Friedman et al. discloses a topically applicable oil in glycerine composition. The composition comprising vegetable oil, essential oil and emulsifier. The emulsifier is of vegetable origin. The composition is alcohol free. US patent no B1 by Farooqi discloses a herbal skin care composition comprising of bees wax, stearic acid, glycerol mbnostearate, olive oil, aloe gel, glycerine, triethanolamine, parabens, propylene glycol, essential oils, sandal wood oil, and rose water. The process for the preparation of composition is also disclosed.

3 Summary of the Invention It is a principal object of the present invention to provide a herbal cream or lotion composition comprising extracts of organically certified herbs, organic essential oils along with pharmaceutically acceptable excipients, wherein said composition is devoid of any chemical contaminations. It is another object of the present invention to provide a herbal cream or lotion composition comprising extracts of organically certified herbs, organic essential oils along with pharmaceutically acceptable excipients, wherein said composition is the purest and provides superior skin benefits. It is yet another object of the present invention to provide a herbal cream or lotion composition comprising extracts of organically certified herbs, organic essential oils along with pharmaceutically acceptable excipients, wherein said compositions are made using emulsifiers that are made from natural ingredients and are not ethoxylates, with certified organic ingredient as actives and preservatives that are mild example Sorbates, and enzymes. Further the object is to provide a method of preparing a herbal cream or lotion composition comprising extracts of organically certified herbs, organic essential oils along with pharmaceutically acceptable excipients, wherein said method is devoid of using any solvent. The above and the other objects of the present invention are attended according to the following preferred embodiments of the present invention, however the scope of the invention is not restricted to the particular embodiment. In accordance with one embodiment of the present invention, there is provided a herbal cream or lotion composition comprising extracts of organically certified herbs, organic essential oils along with pharmaceutically acceptable excipients, wherein the extract is prepared employing a super critical fluid extraction or water extraction. In accordance with another embodiment of the present invention, there is provided a herbal cream or lotion composition comprising extracts of organically excipients, wherein the extract of herbs is obtained from a blend of herbs selected from Glycyrrhiza glabra, Asparagus racemosus, Tinospora cordifolia, Sida cordifolia, Camellia sinensis or various combinations thereof.

4 In accordance with one other embodiment of the present invention, there is provided a herbal cream or lotion composition comprising extracts of organically excipients, wherein the blend is used in the range of % to 0.5%. Preferably the blend is used in the range of % to %. In accordance with one other embodiment of the present invention, there is provided a herbal cream or lotion composition comprising extracts of organically excipients, wherein the organic essential oils is used in the range of 0.01% to 5%. In accordance with one other embodiment of the present invention, there is provided a herbal cream or lotion composition comprising extracts of organically excipients, wherein said composition is formulated in lotion and cream formulation. In accordance with yet another embodiment of the present invention, there is provided a herbal cream or lotion composition comprising extracts of organically excipients, wherein lotion is Nourishing face moisturising lotion, Revitalizing hand and body lotion. In accordance with yet another embodiment of the present invention, there is provided a herbal cream or lotion composition comprising extracts of organically excipients, wherein cream is Nourishing Night cream. In accordance with yet another embodiment of the present invention, there is provided a herbal cream or lotion composition comprising extracts of organically excipients, wherein the Revitalizing hand and body lotion comprising a herbal blend extract of herbs Glycyrrhiza glabra, Asparagus racemosus, Tinospora cordifolia, Sida cordifolia and essential oils selected from Vetiveria zizanoides, Rosmarinus officinalis, Lavandula latifolia, Syzygium aromaticum, Abelmoschus moschatus and in combination thereof along with pharmaceutically acceptable excipients. In accordance with yet another embodiment of the present invention, there is provided a herbal cream or lotion composition comprising extracts of organically

5 excipients, wherein Nourishing Night cream comprising herbal extract of Camellia sinensis and essentials oils selected from Prunus amygdalus, Vetiveria zizanoides, Cinnamomum zeylanicum, Abelmoschus moschatus, Rosmarinus officinalis, Origanum Majorana, Pogostemon cablin and in combination thereof along with pharmaceutically acceptable excipients. In accordance with yet another embodiment of the present invention, there is provided a herbal cream or lotion composition comprising extracts of organically excipients, wherein said composition is prepared by the process comprising blending the organically certified herbs and extracting the resultant herbs employing super critical fluid extraction (SCFE), mixing the resultant extract blend with organic essential oils and mixing pharmaceutically acceptable excipients. In accordance with yet another embodiment of the present invention, there is provided a herbal cream or lotion composition comprising extracts of organically excipients, wherein said composition is prepared by the process comprising blending the organically certified herbs and extracting the resultant herbs employing percolation or soxhlation using water, mixing the resultant extract of blend with organic essential oils and mixing pharmaceutically acceptable excipients. Description of the Invention While this specification concludes with claims particularly pointing out and distinctly claiming that, which is regarded as the invention, it is anticipated that the invention can be more readily understood through reading the following detailed description of the invention and study of the included examples. The present invention is about creams and lotions that are made using emulsifiers that are made from natural ingredients and are not ethoxylates, with certified organic ingredient as actives and preservatives that are mild example Sorbates, and enzymes. The present invention describes the preparation of body creams such as nourishing night cream, anti blemish cream, anti acne cream, age-defying cream, under eye cream, foot care cream and body lotions such as face moisturizing lotion, revitalizing hand and body lotion using organic bees wax, organic vegetable oils,

6 organic herbal actives along with non-ethoxylated emulsifiers and other components for the various skin benefits. The excipients used herein according to the present invention are selected from water, emollients, foaming agent, preservative, thickener or viscosity enhancer, fixative, vegetable oil and antioxidant. The essential oils used herein according to present invention is selected from Prunus amygdalus, Vetiveria zizanoides, Cinnamomum zeylanicum, Coriandrum sativum, Lavandula latifolia, Syzygium aromaticum, Abelmoschus moschatus, Rosmarinus officinalis, Origanum Majorana, Pogostemon cablin or a combination thereof. In accordance with the present invention the organic essential oils are used herein obtained by cold press method. The following non-limiting examples illustrate in details about the invention. However, they are, not intended to be limiting the scope of present invention in any way. Example 1 Nourishing Face Moisturizing Lotion:

7 Example 2 Manufacturing Procedure 1. Blend and keep Phase G ingredients 2. Take DM Water (Phase A) in the main vessel. Heat to boil and cool to 8O 0 C 53. Heat Phase B to 8O 0 C 4. Disperse Xanthan gum and Carrageen an in glycerin (Phase C). Ensure that no lumps are formed 5. Transfer Phase C to Phase A. Mix for 15 min. Maintain the temperature at 8O 0 C 6. Transfer Phase B to the main vessel at 8O 0 C. Mix for 20 min at 20 rpm only 107. Start Cooling with continuous mixing at 20 rpm. 8. Transfer Soliga honey (Phase D) and Natural Vitamin E (Phase E )to the main vessel at 45 0 C. Mix thoroughly. 9. Phase F to the main vessel at less than 4 O 0 C. 10. Add Perfume blend (Phase G) and Mix well for 15 mins A U organic oils are procured locally. Example 3 Revitalizing Hand and Body Lotion :

8 Example 4 Manufacturing Procedure 1. Blend and keep Phase G ingredients 2. Take DM Water (Phase A) in the main vessel. Heat to boil and cool to 8O 0 C 53. Heat Phase B to 8 O 0 C 4. Disperse Xanthan gum in glycerin (Phase C). Ensure that no lumps are formed 5. Transfer Phase C to Phase A. Mix for 15 min. Maintain the temperature at 8O 0 C 6. Transfer Phase B to the main vessel at 8O 0 C. Mix for 20 min at 20 rpm only 7. Start Cooling with continuous mixing at 20 rpm.

9 8. Transfer Soliga honey (Phase D ) and Natural Vitamin E (Phase E )to the main vessel at 45 0 C. Mix thoroughly. 9. Mix Glucose Solution and Enzyme Solution (phase F) and add to the main vessel at at less than 4 O 0 C Add Perfume blend (Phase G) and Mix well for 15 mins. 11. All organic oils are procured locally. 12. The preparation of extracts is given in examples. Example 5 Nourishing Night Cream: 0

10 Example 6 Manufacturing Procedure 1. Blend and keep Phase G ingredients 2. Take DM Water (Phase A) in the main vessel. Heat to boil and cool to 8O 0 C 53. Heat Phase B to 8O 0 C 4. Disperse Xanthan and Carrageen an in glycerin (Phase C). Ensure that no lumps are formed 5. Transfer Phase C to Phase A. Mix for 15 min. Maintain the temperature at 8O 0 C 6. Transfer Phase B to the main vessel at 8O 0 C. Mix for 20 min at 20 rpm only 107. Start Cooling with continuous mixing at 20 rpm. 8. Transfer Soliga honey (Phase D )and Natural Vitamin E (Phase E )to the main vessel at 45 0 C. Mix thoroughly. 9. Add Phase F and add to the main vessel at less than 4 O 0 C. 10. Add Perfume blend (Phase G) and Mix well for 15 mins All oils were procured locally. Example 7 Preparation of extract from Organic Glycyrrhiza glabra roots Extract by Super Critical Fluid Extraction The dried material of Glycyrrhiza glabra roots was pulverized to coarse 20 powder and about 25 Kg of powdered material was placed in a SCF extractor at the temperature of 40-50C at high pressure of bar using carbon dioxide as super critical fluid for extraction upto 4 to 6 hours and then the extract was collected in the collection vessel and evaporated at room temperature to remove any further residues of carbon dioxide. The extract thus obtained was free from any solvent residues and in 25 highest pure form. Example 8 Preparation of extract from Organic Asparagus racemosus roots by Super Critical Fluid Extraction

11 The dried material of Asparagus racemosus roots was pulverized to coarse powder and about 25 Kg of powdered material was placed in a SCF extractor at the temperature of 40-50C at high pressure of bar using carbon dioxide as super critical fluid for extraction upto 4 to 6 hours and then the extract was collected in the collection vessel and evaporated at room temperature to remove any further residues of carbon dioxide. The extract thus obtained was free from any solvent residues and in highest pure form. Example 9 Preparation of extract from Organic Tinospora cordifolia stem by Super Critical Fluid Extraction The dried material of Tinospora cordifolia stem was pulverized to coarse powder and about 25 Kg of powdered material was placed in a SCF extractor at the temperature of 40-50C at high pressure of bar using carbon dioxide as super critical fluid for extraction upto 4 to 6 hours and then the extract was collected in the collection vessel and evaporated at room temperature to remove any further residues of carbon dioxide. The extract thus obtained was free from any solvent residues and in highest pure form. Example 10 Preparation of extract from Organic Sida cordifolia roots by Super Critical Fluid Extraction The dried material of Sida cordifolia roots was pulverized to coarse powder and about 25 Kg of powdered material was placed in a SCF extractor at the temperature of 40-50C at high pressure of bar using carbon dioxide as super critical fluid for extraction upto 4 to 6 hours and then the extract was collected in the collection vessel and evaporated at room temperature to remove any further residues of carbon dioxide. The extract thus obtained was free from any solvent residues and in highest pure form. Example 11 Preparation of extract from herbal blend by Super Critical Fluid Extraction The shade dried material of herbal blend of Glycyrrhiza glabra roots and/or Asparagus racemosus roots and /or Tinospora cordifolia stem and/or Sida cordifolia roots in the ratio of 1:1:1:1 respectively was pulverized to coarse powder and about

12 100 Kg of powdered herbal blend was placed in a SCF extractor at the temperature of 40-50C at high pressure of bar using carbon dioxide as super critical fluid for extraction upto 4 to 6 hours and then the extract was collected in the collection vessel and evaporated at room temperature to remove any further residues of carbon dioxide. The extract thus obtained was free from any solvent residues and in highest pure form. Example 12 Preparation of extract from Glvcyrrhiza glabra roots by hot-soxhlation / cold percolation method: The coarse powdered dried roots of Glycyrrhiza glabra were subjected to hot-soxhlation by placing 10 Kg of material in soxhlator using water as solvent of extraction at refluxing temperature and recycled the process until extraction is completed, then plant extracts were filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature. The herbal material was also placed in percolator and extracted with water at room temperature for 24 h to 48 h., then plant extract was filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature and under reduced pressure. Example 13 Preparation of aqueous extract from Asparagus racemosus roots by hotsoxhlation / cold percolation method: The coarse powdered dried roots of Asparagus racemosus were subjected to hot-soxhlation by placing 10 Kg of material in soxhlator using water as solvent of extraction at refluxing temperature and recycled the process until extraction is completed, then plant extracts were filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature. The herbal material was also placed in percolator and extracted with water at room temperature for 24 h to 48 h., then plant extract was filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature and under reduced pressure. Example 14 Preparation of aqueous extract from Tinospora cordifolia stem by hotsoxhlation / cold percolation method: The coarse powdered dried roots of Tinospora cordifolia stem were subjected to hot-soxhlation by placing 10 Kg of material in soxhlator using water as solvent of

13 extraction at refluxing temperature and recycled the process until extraction is completed, then plant extracts were filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature. The herbal material was also placed in percolator and extracted with water at room temperature for 24 h to 48 h., then plant extract was filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature and under reduced pressure. Example 15 Preparation of aqueous extract from Sida cordifolia roots by hot-soxhlation / cold percolation method: The coarse powdered dried roots of Sida cordifolia roots were subjected to hot-soxhlation by placing 10 Kg of material in soxhlator using water as solvent of extraction at refluxing temperature and recycled the process until extraction is completed, then plant extracts were filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature. The herbal material was also placed in percolator and extracted with water at room temperature for 24 h to 48 h., then plant extract was filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature and under reduced pressure. Example 16 Preparation of extract from herbal blend by aqueous Extraction The shade dried material of herbal blend of Glycyrrhiza glabra roots and/or Asparagus racemosus roots and /or Tinospora cordifolia stem and/or Sida cordifolia rootsjn the ratio of 1:1:1:1 respectively was pulverized to coarse powder and about 100 Kg of powdered herbal blend was placed in soxlator using water as solvent of extraction at refluxing temperature and recycled the process until extraction is completed, then plant extracts were filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature. The herbal material was also placed in percolator and extracted with water at room temperature for 24 h to 48 h., then plant extracts were filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature and under reduced pressure. Example 17 Preparation of extract from Organic Camellia sinensis leaves by Super Critical Fluid Extraction

14 The dried material of Camellia sinensis leaves was pulverized to coarse powder and about 25 Kg of powdered material was placed in a SCF extractor at the temperature of 40-50C at high pressure of bar using carbon dioxide as super critical fluid for extraction upto 4 to 6 hours and then the extract was collected in the collection vessel and evaporated at room temperature to remove any further residues of carbon dioxide. The extract thus obtained was free from any solvent residues and in highest pure form. Example- 18 A clinical study to evaluate the moisturizing efficacy of Nourishing Face Lotion on healthy human Volunteers A study was conducted to evaluate moisturizing effect of Nourishing Face Lotion and after-application feel in 10 healthy human subjects (5 male and 5 female) were enrolled into the study based on the inclusion criteria as per protocol; the investigational product was applied on the left and right forearms. A total of 15 and 10 sites were evaluated for treated and untreated, respectively. Moisturizing effect of treated and untreated site was evaluated using Corneometer 825. In addition after application feel was evaluated by self assessment by individual subject using 5 point scale (1= Poor; 2= Average; 3= Good; 4=Very Good; 5=Excellent). All the evaluations were done on a linear analogue scale. All the values are expressed as Mean ± SD. Statistical analysis was performed using repeated measures of ANOVA followed by Dunnett's multiple comparison test. After application feel was evaluated using Friedman test followed by Dunnett's multiple comparison test. The minimum level of significance was fixed at 95% confidence limit. Analysis was performed using GraphPad Prism version 4.03 for Windows, GraphPad Software, San Diego California USA, Table 1: Moisturizing Efficacy of Nourishing Face Lotion as Evaluated by Corneometer Readings.

15 V<0.01 as compared to baseline values. No statistical significance was observed in the untreated group at various time points of post application as compared to the baseline values. Table 2 : After Application Feel of Nourishing Face Lotion- Self Assessment by Individual Subjects All the 10 subjects completed the study. The outcome of the study showed a significant moisturizing effect as evaluated by Corneometer reading in the Nourishing Face Lotion treated group after application. There was also an increasing trend in the Corneometer reading at 2, 4, 6, and 8 h post application as compared to the baseline values but was not significant. No significant effect was observed in the untreated group as compared to the base line values at any of the time points (Table 1). Evaluation of after feel application by individual subject self assessment revealed a significant improvement in all the parameters namely softness, smoothness, overall appearance and moisturization. All these self assessment parameters were not statistically significant in the untreated group except for significance for smoothness at 2 h post application. (Table 2). None of the subjects reported of adverse events in this study. The observations clearly support the Efficacy and safety of Nourishing Face Lotion as evaluated by various parameters in this study. Example- 19

16 A clinical study to evaluate the moisturizing efficacy of Revitalizing Hand and Body Lotion on healthy human Volunteers A study was conducted to evaluate moisturizing effect of Revitalizing Hand and Body Lotion and after-application feel in 10 healthy human subjects (5 male and 5 female) were enrolled into the study based on the inclusion criteria as per protocol; the investigational product was applied on the left and right forearms. A total of 15 and 10 sites were evaluated for treated and untreated, respectively. Moisturizing effect of treated and untreated site was evaluated using Corneometer 825. In addition after application feel was evaluated by self assessment by individual subject using 5 point scale (1= Poor; 2= Average; 3= Good; 4=Very Good; 5=Excellent). All the evaluations were done on a linear analogue scale. All the values are expressed as Mean ± SD. Statistical analysis was performed using repeated measures of ANOVA followed by Dunnett's multiple comparison test. After application feel was evaluated using Friedman test followed by Dunnett's multiple comparison test. The minimum level of significance was fixed at 95% confidence limit. Analysis was performed using GraphPad Prism version 4.03 for Windows, GraphPad Software, San Diego California USA, Table 3 : Moisturizing Efficacy of Revitalizing Hand and Body Lotion as Evaluated by Corneometer Readings.

17 Table 4 : After Application Feel of Revitalizing Hand and Body Lotion - Self Assessment by Individual Subjects All the 10 subjects completed the study. The outcome of the study showed a significant moisturizing effect as evaluated by Corneometer reading in the Revitalizing Hand and Body Lotion treated group at various time points and moisturizing effect was significant even at 8 h post application. No significant effect was observed in the untreated group as compared to the base line values (Table 3). Evaluation of after feel application by individual subject self assessment revealed a significant improvement in all the parameters namely softness, smoothness, overall appearance and moisturization. All these self assessment parameters were not statistically significant in the untreated group except for smoothness at 2 hour post application (Table 4). None of the subjects reported of adverse events in this study. The observations clearly support the Efficacy and safety of Revitalizing Hand and Body Lotion as evaluated by various parameters in this study. Example-20 A clinical study to evaluate the moisturizing efficacy of Nourishing Night Cream on healthy human Volunteers A study was conducted to evaluate moisturizing effect of Nourishing Night Cream and after-application feel in 10 healthy human subjects (5 male and 5 female) were enrolled into the study based on the inclusion criteria as per protocol; the

18 investigational product was applied on the left and right forearms. A total of 15 and 10 sites were evaluated for treated and untreated, respectively. Moisturizing effect of treated and untreated site was evaluated using Corneometer 825. In addition after application feel was evaluated by self assessment by individual subject using 5 point scale (1= Poor; 2= Average; 3= Good; 4=Very Good; 5=Excellent). All the evaluations were done on a linear analogue scale. All the values are expressed as Mean ± SD. Statistical analysis was performed using repeated measures of ANOVA followed by Dunnett's multiple comparison test. After application feel was evaluated using Friedman test followed by Dunnett's multiple comparison test. The minimum level of significance was fixed at 95% confidence limit. Analysis was performed using GraphPad Prism version 4.03 for Windows, GraphPad Software, San Diego California USA, Table 5: Moisturizing Efficacy of Nourishing Night Cream as Evaluated by Corneometer Readings. Table 6 : After Application Feel of Nourishing Night Cream- Self Assessment by Individual Subjects

19 Overall c 3.20 c 3.47 Appearance ± 1.08 ± 1.08 ± 0.97 ± 0.57 ± 1.05 ± 0.49 ± 0.68 ± 0.74 Moisturization a 3.27 c 3.33 ± 1.03 ± 1.17 ± 1.17 ± 0.88 ± 0.99 ± 0.82 ± 0.70 ± 0.82 V<0.001, a p<0.01 and c /?<0.05 as compared to baseline values, No statistical significance was observed in the untreated group at various time points of post application as compared to the baseline values. All the 10 subjects completed the study. The outcome of the study showed a significant moisturizing effect as evaluated by Corneometer reading in the Nourishing Night Cream treated group at various time points and moisturizing effect was significant even at 8 h post application. No significant effect was observed in the untreated group as compared to the base line values (Table 5). Evaluation of after feel application by individual subject self assessment revealed a significant improvement in all the parameters namely softness, smoothness, overall appearance and moisturization. All these self assessment parameters were not statistically significant in the untreated group (Table 6). None of the subjects reported of adverse events in this study. The observations clearly support the Efficacy and safety of Nourishing Night Cream as evaluated by various parameters in this study. While this invention has been described in detail with reference to certain preferred embodiments, it should be appreciated that the present invention is not limited to those precise embodiments. Rather, in view of the present disclosure, which describes the current best mode for practicing the invention, many modifications and variations would present themselves to those skilled in the art, without departing from the scope and spirit of this invention.

20 We claim: 1. A herbal cream or lotion composition comprising extracts of organically certified herbs organic essential oils along with pharmaceutically acceptable excipients, wherein the extract is prepared employing a super critical fluid extraction or water extraction. 2. The composition according to claim 1, wherein the extract of herbs is obtained from a blend of herbs selected from Glycyrrhiza glabra, Asparagus racemosus, Tinospora cordifolia, Sida cordifolia, Camellia sinensis or various combinations thereof. 3. The composition according to claim 1, wherein the excipients are selected from water, emollients, foaming agent, preservative, thickener or viscosity enhancer, fixative, vegetable oil and antioxidant. 4. The composition according to claim 1, wherein the essential oil is selected from Prunus amygdalus, Vetiveria zizanoides, Cinnamomum zeylanicum, Coriandrum sativum, Lavandula latifolia, Syzygium aromaticum, Abelmoschus moschatus, Rosmarinus officinalis, Origanum Majorana, Pogostemon cablin or a combination thereof. 5. The composition according to claim 4, wherein the organic essential oils is obtained by cold press method. 6. The composition according to claim 2, wherein the blend is used in the range of % to 0.5%. 7. The composition according to claim 6, wherein the blend is used in the range of % to %. 8. The composition according to claim 1, wherein the organic essential oils is used in the range of 0.0 1% to 5%. 9. The composition according to claim 1, wherein said composition is formulated in lotion and cream formulation. 10. The composition according to claim 9, wherein lotion is Nourishing face moisturising lotion, Revitalizing hand and body lotion. 11. The compositon according to claim 9, wherein the Revitalizing hand and body lotion comprising a herbal blend extract of herbs Glycyrrhiza glabra, Asparagus racemosus, Tinospora cordifolia, Sida cordifolia and essential oils selected from Vetiveria zizanoides, Rosmarinus officinalis, Lavandula latifolia,

21 Syzygium aromaticum, Abelmoschus moschatus and in combination thereof along with pharmaceutically acceptable excipients. 12. The composition according to claim 9, wherein cream is Nourishing Night cream. 13. The composition according to claim 12, wherein Nourishing Night cream comprising herbal extract of Camellia sinensis and essentials oils selected from Prunus amygdalus, Vetiveria zizanoides, Cinnamomum zeylanicum, Abelmoschus moschatus, Rosmarinus officinalis, Origanum Majorana, Pogostemon cablin and in combination thereof along with pharmaceutically acceptable excipients. 14. The composition according to claim 1, wherein said composition is prepared by the process comprising blending the organically certified herbs and extracting the resultant herbs employing super critical fluid extraction (SCFE), mixing the resultant extract blend with organic essential oils and mixing pharmaceutically acceptable excipients. 15. The composition according to claim 1, wherein said composition is prepared by the process comprising blending the organically certified herbs and extracting the resultant herbs employing percolation or soxhlation using water, mixing the resultant extract of blend with organic essential oils and mixing pharmaceutically acceptable excipients.