Formulation and optimization of water soluble granules of Withania Somnifera

Abstract

Herbal medicines have great demand in the treatment of various kinds of illness.  Ayurvedic system of medicine has consisted of many herbal sources in which ashwagandha one of them which are the very popular herbal sources. Many literature surveys suggest that ashwagandha is used as an immunomodulator, tranquilizer, antioxidant, antidiabetic, and nootropic activity. Present research work explored the potential benefit of ashwagandha by designing suitable granules of its water extract. Further, it is characterized by various parameters and In-vitro drug release


Keywords: Immunomodulator, Tranquilizers Ayurvedic, Ashwagandha, Granules

Keywords: Immunomodulator, Tranquilizers, Ayurvedic, Ashwagandha, Granules

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Author Biographies

Dilip Kumar Tiwari, Lakshmi Narain College of Pharmacy, Bhopal, M.P., India

Lakshmi Narain College of Pharmacy, Bhopal, M.P., India

Kaushelendra Mishra, Lakshmi Narain College of Pharmacy, Bhopal, M.P., India

Lakshmi Narain College of Pharmacy, Bhopal, M.P., India

Neelima Mishra, Lakshmi Narain College of Pharmacy, Bhopal, M.P., India

Lakshmi Narain College of Pharmacy, Bhopal, M.P., India

Neeraj Upmanyu, Lakshmi Narain College of Pharmacy, Bhopal, M.P., India

Lakshmi Narain College of Pharmacy, Bhopal, M.P., India

References

1. Balammal G, Sekar BM, Reddy JP. Analysis of Herbal Medicines by Modern Chromatographic Techniques. International Journal of Preclinical and Pharmaceutical Research. 2012; 3(1):50-63.
2. Pal KS, Shukla Y. Herbal Medicine: Current Status and the Future. Asian Pacific J Cancer Prev. 2003; 4:281-88.
3. Kashaw V, Nema AK, Agarwal A. Hepatoprotective Prospective of Herbal Drugs and Their Vesicular Carriers– A Review. International Journal of Res1. Balammal G, Sekar BM, Reddy JP. Analysis of Herbal Medicines by Modern Chromatographic Techniques. International Journal of Preclinical and Pharmaceutical Research. 2012; 3(1):50-63. https://doi.org/10.1155/2012/809541
2. Pal KS, Shukla Y. Herbal Medicine: Current Status and the Future. Asian Pacific J Cancer Prev. 2003; 4:281-88.
3. Kashaw V, Nema AK, Agarwal A. Hepatoprotective Prospective of Herbal Drugs and Their Vesicular Carriers– A Review. International Journal of Research in Pharmaceutical and Biomedical Sciences. 2011; 2(2):4-9.
4. Prabhu TP, Panneerselvam P, kumar RV, Atlee WC, Subramanian SB. Anti- inflammatory, anti arthritis and analgesic effect of ethanolic extract of whole plant of Merremia emarginata Burm. F. Central European Journal of Experimental Biology. 2012; 1(3):94-99.
5. Patel P, Patel D, Patel N. Experimental investigation of anti-rheumatoid activity of Pleurotus sajorcaju in adjuvant -induced arthritic rats. Chinese Journal of Natural Medicines. 2012; 10(4):269-74. https://doi.org/10.1016/S1875-5364(12)60054-5
6. Avalaskar A, Kudale P, Khandelwal P, Natesan S, Shah P, Jadhav R. Formulation and Evaluation of Oral Herbal Granules For Asthma, International Journal of Pharma Sciences and Research. 2016; 7(10):4-10.
7. McKenna A, Mc Cafferty DF, J. Pharm. Pharmacol, 1982; 34(6):347-51.earch in Pharmaceutical and Biomedical Sciences. 2011; 2(2):4-9.
4. Prabhu TP, Panneerselvam P, kumar RV, Atlee WC, Subramanian SB. Anti- inflammatory, anti arthritis and analgesic effect of ethanolic extract of whole plant of Merremia emarginata Burm. F. Central European Journal of Experimental Biology. 2012; 1(3):94-99.
5. Patel P, Patel D, Patel N. Experimental investigation of anti-rheumatoid activity of Pleurotus sajorcaju in adjuvant -induced arthritic rats. Chinese Journal of Natural Medicines. 2012; 10(4):269-74.
6. Agarwal P, Fatima A Singh PP. Herbal Medicine Scenario in India and European Countries. Journal of Pharmacognosy and Phytochemistry. 2012; 1(4):3-11.
7. Gautam RK, Singh D, Nainwani R. Medicinal Plants having Anti-arthritic Potential: A Review. Int. J. Pharm. Sci. Rev. Res. 2013; 19(1):96-102.
8. Patil RB, Vora SR, Pillai MM. Protective effect of Spermatogenic activity of Withania somnifera (Ashwagandha) in galactose stressed mice. Annals of Biological Research. 2012; 3(8):4159-65.
9. Brown HM, Christie AB, Colin EJ. Glycyrrhetinc acid hydrogen succinate (disodium) salt: a new anti-inflammatory compound. Lancet. 1959; 2:492.
10. Adami E, Marzzi EU, Turba C. Arch Int Pharmaco dyn Tuer. 1964: 147:113.
11. Kamboj VP. Herbal medicine. Current science. 2000; 78(1):12-18.
12. Partap S, Kumar A, Sharma NK, Jha KK. Luffa Cylindrica: An important medicinal plant. J. Nat. Prod. Plant Resour. 2012; 2(1):127-34.
13. Verma S, Singh SP. Current and future status of herbal medicines. Veterinary World. 2008; 1(11):347-50.

14. Padmawar A, Bhadoria U. Phytochemical investigation and comparative evaluation of in vitro free radical scavenging activity of Triphala & Curcumin. Asian Journal of Pharmacy and Medical Science. 2011; 1(1): 9-12.
15. Ampofo AJ, Andoh A, Tetteh W, Bello M. Microbiological Profile of Some Ghanaian Herbal Preparations-Safety Issues and Implications for the Health Professions. Open Journal of Medical Microbiology. 2012; 2:121-30.
16. Mosihuzzaman M, Choudhary MI. Protocols on Safety, Efficacy, Standardization, and Documentation of Herbal Medicine. Pure Appl. Chem. 2008; 80(10):2195–30.
17. Rukangira E. The African Herbal Industry: Constraints and Challenges, proc: “The natural Products and Cosmeceuticals 2001conference”. Africa. 2000; 1-20.
18. Kamboj A. Analytical Evaluation of Herbal Drugs. Drug Discovery Research in Pharmacognosy. 2012; 3:23- 55.
19. Anonymous. Handbook of Pharmaceutical Granulation Technology. 3rd ed. Parikh DM, editor. Marcel Dekker, INC. 2009.
20. Anonymous. Pharmaceutics: The Science of Dosage Form Design. 2nd ed. Churchill Livingstone; 2001.
21. BJ E, J L. Size enlargement and size reduction. In: Green Don W, PR H, editors. Perry‟s Chemical Engineers‟ Handbook. 7th ed. New York: McGraw-Hill; 1994.
22. BJ E. Solids-solids processing. In: D G, P R, editors. Perry‟s Chemical Engineers‟ Handbook. 8th ed. New York: McGraw Hill; 2005.
23. Iveson SM, Litster JD, Hapgood K, Ennis BJ. Nucleation, growth and breakage phenomena in agitated wet granulation processes: a review. Powder Technology. 2001; 117:3–39.
24. Shimodaira S et al. Quality Verification of Dendritic Cell-Based Cancer Vaccine. Pharm Anal Acta. 2016; 7:465.
25. Hassali MA et al. Role of Pharmacists in Health-Based Non-Governmental Organizations NGO: Prospects and Future Directions. Pharm Anal Acta. 2016; 7:467.
26. Vergeire-Dalmacion G. Usefulness of Cost Effectiveness: Evidence versus Applicability. Pharm Anal Acta. 2016; 7:456.
27. Wang C. Application of In Vitro Models in Developmental Neurotoxicity and Pharmaceutics Research. J Mol Pharm Org Process Res. 2015; 3:122.

28. Lyubchenko YL. Nanoimaging for Molecular Pharmaceutics of Alzheimer‟s and other Neurodegenerative Disorders. J Mol Pharm Org Process Res. 2013; 1:107.
29. Skalko-Basnet N. Note on the “Molecular Pharmaceutics and Organic Process”. J Mol Pharm Org Process Res. 2013; 1:104.
30. Foldvari M. Nanopharmaceutics Innovations in Gene Therapy: Moving Towards Non-Viral and Non-Invasive Delivery Methods. J Nanomedine Biotherapeutic Discov. 2014; 4:135.
31. Qumbar M et al. DOE Based Stability Indicating RP-HPLC Method for Determination of Lacidipine in Niosomal Gel in Rat: Pharmacokinetic Determination. Pharm Anal Acta. 2014; 5:314.
32. Abbas-Aksil T et al. Matrix Tablets from Algerian Lyophilized Berries LB Arbutus unedo L. Date Phoenix dactylifera L.0020 Nat Prod Chem Res. 2016; 4:207.
33. Oshizumi Y et al. Dynamics of Swallowing Tablets during the Recovery Period following Surgery for Tongue Cancer. Otolaryngology. 2016; 6:218.
34. Kubo Y et al. Interventional Evaluation of Monoammonium Glycyrrhizinate- Glycine/DL Methionine Combination Tablets in Mild Alopecia Areata. J Clin Exp Dermatol. 2016; 7:322.
35. Belafkih B et al. LCMS/ MS Analysis of MDMA in Ecstasy Tablets in Morocco. J Forensic Res. 2015; 6:301.
36. Vargas M et al. Bioequivalence Study of Two Formulations Containing Rosuvastatin 40 Mg Tablets in Healthy Colombians. J Bioequiv Availab. 2015; 7:229-32.
37. Bustami R et al. Bioequivalence of Losartan/Amlodipine Fixed Dose Combination Tablets Losanet AM Compared with Concomitant Administration of Single Components of Losartan and Amlodipine Tablets in Healthy Human Volunteers. J Bioequiv Availab. 2015; 7:216-24.
38. Vargas M et al. Fed and Fasting Bioequivalence Study for Two Formulations of Bosentan 125 Mg Tablets in Healthy Colombian People. J Bioequiv Availab. 2015; 7:210-15.
39. Muñoz E et al. Bioequivalence Study of Two Formulations of Escitalopram Oxalate 20 mg Tablets in Healthy Volunteers. J Bioequiv Availab. 2015; 7:205- 209.

40. Sallam A et al. Bioequivalence of Two Oral Formulations of Modafinil Tablets in Healthy Male Subjects Under Fed and Fasting Conditions. J Bioequiv Availab. 2015; 7:63-67.
41. Agatonovic-Kustrin S et al. Biorelevant Dissolution Studies of Pioglitazone HCL Immediate Release Tablets and the Determination of an In Vitro In Vivo Correlation. J Bioequiv Availab. 2015; 7:86-89.
42. Damodar R et al. Formulation and Evaluation of Fast Dissolving Tablets of Diclofenac Sodium by Novel Hole Technology. J Mol Pharm Org Process Res. 2014; 2:116.
43. Malhotra B et al. Relative Bioavailability Study of an Abuse-Deterrent Formulation of Extended-Release Oxycodone with Sequestered Naltrexone ALO-02 Versus Immediate-Release Oxycodone Tablets in Healthy Volunteers. J Bioequiv Availab. 2014; 6:186-91.
44. Zhang X and Zhang S. Bioequivalence Study of Two 30 Mg Tolvaptan Tablets Formulations in Healthy Chinese under Fed Condition. J Bioequiv Availab. 2014; 6:181-85.
45. Devineni D et al. Bioequivalence of Canagliflozin/Metformin Immediate Release Fixed-Dose Combination Tablets Compared with Concomitant Administration of Single Components of Canagliflozin and Metformin in Healthy Fed Participants. J Bioequiv Availab. 2014; 6:164-73.
46. Kumari KP et al. Stability Indicating RP-HPLC method Development and Validation of Salicylic Acid in Choline Magnesium Trisalicilate Trilisate Tablets. J Pharma Care Health Sys. 2014; 1:120.
47. Kassem MA and El-Sayed GO. Adsorption of Tartrazine on Medical Activated Charcoal Tablets under Controlled Conditions. J Environ Anal Chem. 2014; 1:102.
48. De Figueiredo NB et al. Determination of 3,4-methylenedioxymethamphetamine MDMA in Confiscated Tablets by High-Performance Liquid Chromatography HPLC with Diode Array Detector. J Forensic Res. 2010; 1:106.
49. Damodar R et al. Role of Novel Hole Technology in Fast Dissolving Tablets. J Mol Pharm Org Process Res. 2014; 2:1-001.
50. Friedrich C et al. Bioequivalence of Glucophage® Metformin Tablets from Europe and the United States Tested in Healthy Volunteers. J Bioequiv Availab. 2014; 6:61-66.
51. Salem H et al. Simultaneous Determination of Omeprazole, Tinidazole, and Clarithromycin in Bulk Powder and Helicure® Tablets by HPLC. J Chromatograph Separat Techniq. 2014; 5:221.
52. Abdul Althaf S et al. Formulation, Evaluation and Mathematical Modelling of Clopidogrel Bisulphate & Aspirin Immediate Release Bilayer Tablets. Pharmaceut Anal Acta. 2012; 3:194.
53. Biswas D and Halquist M. Using Biorelevant in Vitro Models Testing to Characterize Release of Non Oral Dosage Forms as another Tool for Safety. J Pharmacovigil. 2016; 4:153.
54. Bhattacharjee J. Mass Drugs Administration in India -A Failure Story. Epidemiology (Sunnyvale). 2016; 6:252.
55. Swain S and Beg S. Emergence in the Lipid-Based Nanostructured Systems for Optimizing Oral Delivery of Drugs. Pharmaceut Reg Affairs. 2016; 5:157.
56. Maia Campos PMBG et al. An Oral Supplementation Based on Hydrolyzed Collagen and Vitamins Improves Skin Elasticity and Dermis Echogenicity: A Clinical Placebo-Controlled Study. Clin Pharmacol Biopharm. 2015; 4:142.
57. Gelaw BK et al. Prescription Pattern of Injection at Out-Patient Pharmacy Department of Adama Hospital Medical College, Adama, Ethiopia. Clin Pharmacol Biopharm. 2015; 4:146.
58. Kokardekar RR et al. Development and Evaluation of Sustained Release Microspheres of Glibenclamide by Emulsion Solvent Evaporation Method. Clin Pharmacol Biopharm. 2014; 3:127.
59. Cho SK. The Synergistic Effects of Pioglitazone on the Glucose-Lowering Action of Metformin in Relation to OCT1 and Gluts mRNA Expression in Healthy Volunteers. Clin Pharmacol Biopharm. 2015; 3:129.
60. Ehrenpreis ED et al. A Survey of Lawsuits Filed for the Complaint of Tardive Dyskinesia Following Treatment with Metoclopramide. Clin Pharmacol Biopharm. 2015; 4:131.
61. Adnan M et al. Evaluation of Self-Medication Practices and Awareness among Students in Al Qassim Region of Saudi Arabia. Clin Pharmacol Biopharm. 2015; 4:133.
62. Reure J et al. Her2 Positive Metastatic Breast Cancer Patient without Any Sign of Recurrence 5 years after Cessation of Trastuzumab: A Case Report Clin Pharmacol Biopharm. 2015; 4:136.

63. Gavasane AJ and Pawar HA. Synthetic Biodegradable Polymers Used in Controlled Drug Delivery System: An Overview. Clin Pharmacol Biopharm. 2014; 3:121.
64. Aghahowa SE et al. Tolerabilities of Artemisinin-Based Combination Drugs among Patients with Uncomplicated Malaria in a Tertiary Institution Benin City, Nigeria. Clin Pharmacol Biopharm. 2014; 3:123.
65. De Wolf J et al. Evolution of Drug Utilization in Nursing Homes in Belgium. Clin Pha Pharmacol Biopharm. 2014; 3:124.
66. Kaur P, Mathur S, Sharma M, Tiwari M, Srivastava KK, and Chandra R. A biologically active constituent of Withania somnifera (ashwagandha) with antistress activity. Indian J Clin Biochem. 2001; 16(2): 195–98.
67. Giri KR. Comparative study of anti-inflammatory activity of Withania somnifera (Ashwagandha) with hydrocortisone in experimental animals (Albino rats). Journal of Medicinal Plants Studies. 2016; 4(1): 78-83.
68. Saidulu C. Venkateshwar S. Gangadhar R, Vardhan TA. In-vitro Antimicrobial Activity of Withania somnifera Leaf and Root Extracts grown in Heavy Metal toxic soils. International journal of advances in pharmacy, biology, and chemistry. 2014; 3(4):872- 79.
69. Umadevi M, Rajeswari R, Sharmila C, Rahale, S. Selvavenkadesh, Pushpa R, Sampath Kumar KP, Bhowmik D. Traditional And Medicinal Uses of Withania Somnifera. The pharma innovation.2012; 1(9):1-8.
70. Mamta K, Gupta RP. In vitro antibacterial effect of Withania somnifera root extract on Escherichia coli. Veterinary World. 2015; 8(1): 57-60.
71. Sulaiman B, Khalil R, Muhammad D, Fahad A, Ilyas K, Hizbullah, Noreen A, Rabia z, Usman k, Komal H, Irfan U, Abdul M, Azam H, Mujaddad R. Medicinal Activity of Withania somnifera and Otostegia limbata against Selected Bacterial Pathogens. American-Eurasian J. Agric. & Environ. Sci. 2015; 15(9): 1849-53.
72. Raju SK, Basavanna PL, Nagesh HN, Shanbhag AD. A study on the anticonvulsant activity of Withania somnifera (Dunal) in albino rats. National Journal of Physiology, Pharmacy and Pharmacology. 2017; 7(1): 17-21.
73. Singh SP, Tanwer BS, Khan M. Antifungal Potential of Ashwagandha against some Pathogenic fungi. International Journal of Biopharmaceutics. 2010; 1(2): 72-74.

74. Qamar UL, Samiulla, Singh VK, Jamil SS. Phytochemical and Pharmacological Profile of Withania somnifera Dunal: A Review. Journal of Applied Pharmaceutical Science. 2012; 2(1):170-75.
75. Gajarmal A, Shende A, Chothe DS. Antistress activity of ashwagandha (W. somnifera dunal): a review. IAMJ: 2014; 2(3): 387-93.
76. Verma SK, Kumar A. Therapeutic uses of withania somnifera (ashwagandha) with a note on withanolides and its pharmacological actions. Asian Journal of Pharmaceutical and Clinical Research. 2011; 4(1): 1-4.
77. Nadia A, Monzur H, Mottalib MA, Sulaiman SA, Gan SH, Khalil MI. Methanolic extracts of Withania somnifera leaves, fruits and roots possess antioxidant properties and antibacterial activities. BMC Complementary and Alternative Medicine. 2012; 12:175.
78. Vasantharaja R, Subramaniam JR. Withania somnifera Root Extract Enhances Telomerase Activity in the Human HeLa Cell Line. Advances in Bioscience and Biotechnology. 2016; 7:199-204.
79. Jain P, Varshney R. Antimicrobial activity of aqueous and methanolic extracts of Withania somnifera (Ashwagandha). J. Chem. Pharm. Res. 2011; 3(3):260- 63.
80. Kaur N, Niazi J, Bains R. A Review on Pharmacological Profile of Withania somnifera (Ashwagandha). Research and Reviews: Journal of Botanical Sciences.2013;2(4): 6-14.
81. Raut AA, Rege N, Tadvi F, Solanki P, Kene K, Shirolkar S, Pandey S, Vaidya R, Vaidya A. Exploratory study to evaluate tolerability, safety, and activity of Ashwagandha (Withania somnifera) in healthy volunteers. Journal of Ayurveda & Integrative Medicine. 2012; 3(3): 111-14.
82. Ansari AQ, Ahmed SA, Waheed MA, Juned SA. Extraction and determination of antioxidant activity of Withania somnifera Dunal. European Journal of Experimental Biology. 2013; 3(5):502-507.
83. Yadav B, Bajaj A, Saxena M, Saxena AK. In Vitro Anticancer Activity of the Root, Stem and Leaves of Withania Somnifera against Various Human Cancer Cell Lines. Indian Journal of Pharmaceutical Sciences. 2010; 72(5): 659-63.
84. Sharma V, Sharma S, Pracheta, Paliwal R. Withania somnifera: A Rejuvenating Ayurvedic Medicinal Herb for the Treatment of various Human ailments. International Journal of PharmTech Research. 2011; 3(1):187-92.

85. Shahriar M, Alam F, Uddin MMN. Membrane Stabilizing and Thrombolytic Activity of Withania somnifera Root. American Journal of Phytomedicine and Clinical Therapeutics. 2014; 2(2): 252-56.
86. Kirtikar KR, Basu BD. Indian Medicinal Plants. 2nd ed. Vol. III, Lalit Mohan Basu, Allahabad, India 1980; 1774-77.
87. Chopra RN, Nayar SL, Chopra IC. Glossary of Indian Medicinal Plants. Council of Scientific & Industrial Research, New Delhi. 1980; 191, 258.
88. Mukherjee PK. Quality Control of Herbal Drugs, 2nd Edition, Business Horizons, 2007; 2-14.
89. Khandelwal KR. Ed. Practical Pharmacognosy Technique and Experiments, 23rd Edn: 2005; 15.
90. Kokate CK. Ed. Practical Pharmacognosy, 4th Edn., Vallabh Prakashan: 1994; 112:120.
91. Atanassova M, Georgieva S, Ivancheva K. Total phenolic and total flavonoid contents, antioxidant capacity and biological contaminants in medicinal herbs. Journal of the University of Chemical Technology and Metallurgy. 2011; 46(1): 81-88.
92. Avalaskar A, Kudale P, Khandelwal P, Natesan S, Shah P, Jadhav R. Formulation and Evaluation of Oral Herbal Granules For Asthma, International Journal of Pharma Sciences and Research. 2016; 7(10):4-10.
93. A. McKenna, D. F. Mc Cafferty, J. Pharm. Pharmacol, 1982; 34(6):347-51.
94. Gohel MC, Jogani, PD, Bariya SH. Development of Agglomerated Directly Compressible Diluent‟s consisting of brittle & ductile materials, 2003; 8(2): 143-51.
95. Carr RL. Evaluating flow properties of solids. Chem. Eng. 1965; 72:163-68.
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Tiwari D, Mishra K, Mishra N, Upmanyu N. Formulation and optimization of water soluble granules of Withania Somnifera. JDDT [Internet]. 15Nov.2021 [cited 1Dec.2021];11(6):26-0. Available from: https://jddtonline.info/index.php/jddt/article/view/5142