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"Formulation and Evaluation of Herbal Emulgel "
Asst. Prof. Chaitali C. Dongaonkar,
M.Pharm (QA), PGDPL,
Department of Pharmaceutics,
PES Modern College of Pharmacy(For Ladies), Moshi.
1
CONTENTS
• Introduction
• Need and Usefulness
• Drug profile
• Experimental work
• References
2
INTRODUCTION
 Herbal drugs are probably as old as human race
 Incorporation of novel drug delivery system : -
1. Reduce degradation of drug and/or drug loss
2. Reduce harmful side effect
3. Conventional therapy is ineffective due to limited permeation via skin and
problem can be overcome by incorporating novel drug delivery system i.e.
EMULGEL………….!!!!!!!!!!!!
3
Transdermal drug delivery system
Medication through the skin and into the bloodstream
The drug will keep diffusing into the blood for a long period of time
Maintaining the constant concentration of drug in the blood flow
4
Mechanism of drug transfer via skin
5
iiintercellular
follicular transcellular
Why Emulgel ?
6
EMULSION
× Unstable During
Shelf Life GEL
× Hydrophobic drug
can not deliver
× Hydrophilic Drug
limited permeation
via skin
EMULGEL
 Emulsion + Gel = Emulgel
 Stable
 Dual control release
 Hydrophobic drug can be deliver
 Hydrophilic drug enhanced
permeation
Mechanism of action of Emulgel
7
Gel Emulgel
Hydrogel API
Lipid
Evaporation of
solvent
Advantages
Thixotropic
Easily spreadable
Better loading capacity
Greaseless
Controlled drug release
Avoidance of First pass metabolism
Emollient
Non-staining
Longer shelf-life
Pleasing appearance
Enhanced permeability
Site specific
8
Composition of Emulgel
• Aqueous material : Water, Alcohol eg. Ethanol
• Oils : Mineral oils , Paraffins eg. Arachies oil, Light liq. Paraffin
• Emulsifying Agents : Polythene glycol, Stearates, Spans, Tweens
• Penetration Enhancers : Oleic acid, Lecithin, Menthol
• Gelling Agent : CMC, HPMC, Carbapol
9
Preparation method of Emulgel
10
Oil phase Aq. phase
Emulsification
o/w or w/o Emulsion
Incorporation in the Gel base
Emulgel
Herbs used in Rheumatoid Arthritis
11
 Aloe barbadensis Linn
 Withania somnifera Linn
 Boswellia serrata Linn
 Zingiber officinale Linn
 Curcurma longa Linn
 Vitex negundo Linn
 Terminalia Chebula
NOVELTYAND USEFULNESS
1. Incorporation of novel drug delivery system for Herbal Drugs
2. Improving lipid solubility of hydrophilic phytoconstituents
3. Improved drug delivery to deeper skin even blood
4. Recovery treatment for Arthritis
5.Biphasic Drug delivery system for Herbal extract
12
Hirada(Terminalia Chebula)
• Common Name : Hirada, Haritaki
• Biological Name : Terminalia Chebula
• Family : Combretaceae
• Part used : Fruit
• Active Constituents : Gallic acid
• Therapeutic activity :
 Anti-inflammatory
13
Gallic Acid
EXCIPIENT PROFILE
Sr. No. Materials Quantity Use
1. Carbopol 940 1 % Viscosity increasing agent
2. Tween 80 and Span 20 2.2 + 1.8 % Emulsifiers
3. Propylene glycol 7 % Plasticizers
4. Triethanolamine Q.S. Adjuvant for pH adjustment
5. Ethanol 7 % Aqueous phase, Solubilize extract
9. Sesame seed oil 6 % Oily phase, Ant arthritic activity
10. Methyl paraben 0.18 % Preservative
11. Propyl paraben 0.02 % Preservative
12. Deionized Water Q.S. Vehicle
14
Method of Formulation
Step 1 : Formulation of gel :
Weighed quantity of Carbopol
Dispersed in required quantity of deionized water
Stirred at 1500 - 2000 rpm using Mechanical stirrer
Add Triethanolamine to adjust pH 6.0 to 6.5
Gel
15
Step 2 : Formulation of Emulsion
16
Oil Phase Aqueous Phase
Aqueous Phase added
to Oil Phase by gentle
stirring
Cool to room
temperature
Emulsion
Step 3: Formulation of Emulgel :
17
Gel
Emulsion
Mixed in
1:1 with
stirring
Emulgel
EVALUATION TESTS
Physical Parameters:
1. Color
2. Homogenicity
3. Consistency
4. Grittiness
5. Phase separation.
pH
Viscosity
Spreadability
Drug content
Extrudability study
18
EVALUATION TESTS
Swelling Index
In Vitro diffusion study
Stability study
19
RESULT AND DISCUSSION
 In vitro Diffusion Study:
20
REFERENCES
1.American College of Rheumatology. (2012). Rheumatoid Arthritis (1st ed.). Atlanta, DC: Author.
2.Ranade, S.Y & Gaud, R.S. (2013). Current strategies in herbal drug delivery for arthritis: an
overview. International Journal of Pharmaceutical Science and Research, 4(10), 3782-3794.
3.Saroha, K. et al. (2013). Transdermal gels - an alternative vehicle for drug delivery. International
Journal of Pharmaceutical, Chemical and Biological Sciences, 3(3), 495-503.
4.Singla, V. et al. (2012). Emulgel: A New Platform for Topical Drug Delivery. International Journal of
Pharma and Bio Sciences, 3(1), 485-498.
5.Kute, S.B. (2013). Emulsified gel A Novel approach for delivery of hydrophobic drugs: An
overview. Journal of Advanced Pharmacy Education & Research, 3(4), 368-376.
6.Rasool, M & Varalakshmi, P. (2006). Immunomodulatory role of Withania somnifera root powder on
experimental induced inflammation: An in vivo and in vitro study. Vascular Pharmacology, 44(6), 406-
410. Retrieved 1 December, 2014, from
http://www.sciencedirect.com/science/article/pii/S1537189106000747
21
REFERENCES
7.Agrawal et al.. (1999). Studies on immunomodulatory activity of Withania somnifera (Ashwagandha)
extracts in experimental immune inflammation. Journal of Ethnopharmacology, 67(1), 27-35. Retrieved 1
December, 2014, from http://www.sciencedirect.com/science/article/pii/S0378874199000653
8.Verma, S.K & Kumar, A. (2011). Therapeutic uses of withania somnifera (ashwagandha) with a note on
withanolides and its pharmacological actions. Asian Journal of Pharmaceutical and Clinical
Research, 4(1), 1-4.
9.Kumar et al. (2015). Efficacy & safety evaluation of Ayurvedic treatment (Ashwagandha powder & Sidh
Makardhwaj) in rheumatoid arthritis patients: a pilot prospective study. Indian J Med Res, 141(1), 100-106.
10.Sumantran et al. (2007). Chondroprotective potential of root extracts of Withania somnifera in
osteoarthritis. Journal of Bioscience, 32(2), 299–307.
11.Goyal et al. (2011). Novel Anti-Inflammatory Topical Herbal Gels Containing Withania somnifera and
Boswellia serrata. International Journal of Pharmaceutical & Biological Archives, 2(4), 1087-1094.
22
REFERENCES
12.Anwar, E & Ramadon, D. (2014). Formulation and evaluation of gel and emulgel of chili extract
(capsicum frutescens) as topical dosage forms.International Journal of Pharmacy and
Pharmaceutical Sciences, 6(3), 13-16.
13.Marwaha, T.K. (2013). Formulation,Design and Evaluation of Herbal Anti-psoriatic
Emulgel . Journal of Pharmaceutical & Scientific innovation, 2(3), 30-42.
14.Patil et al. (2014). Novel cosmeceutical herbal emulgel for skin care. World Journal of Pharmacy
and Pharmaceutical Sciences, 3(4), 801-811.
15.Mohammed, H.K.P & Nayar, C. (2014). Formulation and Evaluation of Herbal Emulgel of Pothos
scandens Linn for Burn Wound Healing Activity. Journal of Pharmaceutical Science &
Research, 6(2), 63-67.
16.Oswal, T. & Naik, S. (2014). Formulation and evaluation of mefenamic acid emulgel.
International Journal of Pharmaceutical Research and Development, 5(12), 91-100.
23
REFERENCES
17.The Ayurvedic Pharmacopoeia India. Government of India Ministry of Health And Family
Welfare, Department of Ayush, 1(1).
18.(2006). Carbomer, Ethyl Paraben, Methyl Paraben, Menthol, Propylene Glycol, Thymol. In Rowe,
R.C & Sheskey, P.J (Eds), Handbook of Pharmaceutical Excipients (pp. 111-115,287-288,459-
461,624-626,780-781). USA: The Pharmaceutical Press.
19.Dasgupta, P & De, A. (2012). Comparative Standardization Study of Two Marketed Ashwagandha
Churna Formulation. International Journal of Research in Pharmaceutical and Biomedical Sciences,
3(2), 734-741.
20.ICH harmonised tripartite guideline (27 october 1994) Validation of analytical procedure. Text and
methodology Q2 (R1) current step 4 version parent guidlines.
21.Indian pharmacopeia, (2010). The Indian Pharmacopeia Commission, 1, 37-48.
24
25

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Herbal Emulgel.pptx

  • 1. "Formulation and Evaluation of Herbal Emulgel " Asst. Prof. Chaitali C. Dongaonkar, M.Pharm (QA), PGDPL, Department of Pharmaceutics, PES Modern College of Pharmacy(For Ladies), Moshi. 1
  • 2. CONTENTS • Introduction • Need and Usefulness • Drug profile • Experimental work • References 2
  • 3. INTRODUCTION  Herbal drugs are probably as old as human race  Incorporation of novel drug delivery system : - 1. Reduce degradation of drug and/or drug loss 2. Reduce harmful side effect 3. Conventional therapy is ineffective due to limited permeation via skin and problem can be overcome by incorporating novel drug delivery system i.e. EMULGEL………….!!!!!!!!!!!! 3
  • 4. Transdermal drug delivery system Medication through the skin and into the bloodstream The drug will keep diffusing into the blood for a long period of time Maintaining the constant concentration of drug in the blood flow 4
  • 5. Mechanism of drug transfer via skin 5 iiintercellular follicular transcellular
  • 6. Why Emulgel ? 6 EMULSION × Unstable During Shelf Life GEL × Hydrophobic drug can not deliver × Hydrophilic Drug limited permeation via skin EMULGEL  Emulsion + Gel = Emulgel  Stable  Dual control release  Hydrophobic drug can be deliver  Hydrophilic drug enhanced permeation
  • 7. Mechanism of action of Emulgel 7 Gel Emulgel Hydrogel API Lipid Evaporation of solvent
  • 8. Advantages Thixotropic Easily spreadable Better loading capacity Greaseless Controlled drug release Avoidance of First pass metabolism Emollient Non-staining Longer shelf-life Pleasing appearance Enhanced permeability Site specific 8
  • 9. Composition of Emulgel • Aqueous material : Water, Alcohol eg. Ethanol • Oils : Mineral oils , Paraffins eg. Arachies oil, Light liq. Paraffin • Emulsifying Agents : Polythene glycol, Stearates, Spans, Tweens • Penetration Enhancers : Oleic acid, Lecithin, Menthol • Gelling Agent : CMC, HPMC, Carbapol 9
  • 10. Preparation method of Emulgel 10 Oil phase Aq. phase Emulsification o/w or w/o Emulsion Incorporation in the Gel base Emulgel
  • 11. Herbs used in Rheumatoid Arthritis 11  Aloe barbadensis Linn  Withania somnifera Linn  Boswellia serrata Linn  Zingiber officinale Linn  Curcurma longa Linn  Vitex negundo Linn  Terminalia Chebula
  • 12. NOVELTYAND USEFULNESS 1. Incorporation of novel drug delivery system for Herbal Drugs 2. Improving lipid solubility of hydrophilic phytoconstituents 3. Improved drug delivery to deeper skin even blood 4. Recovery treatment for Arthritis 5.Biphasic Drug delivery system for Herbal extract 12
  • 13. Hirada(Terminalia Chebula) • Common Name : Hirada, Haritaki • Biological Name : Terminalia Chebula • Family : Combretaceae • Part used : Fruit • Active Constituents : Gallic acid • Therapeutic activity :  Anti-inflammatory 13 Gallic Acid
  • 14. EXCIPIENT PROFILE Sr. No. Materials Quantity Use 1. Carbopol 940 1 % Viscosity increasing agent 2. Tween 80 and Span 20 2.2 + 1.8 % Emulsifiers 3. Propylene glycol 7 % Plasticizers 4. Triethanolamine Q.S. Adjuvant for pH adjustment 5. Ethanol 7 % Aqueous phase, Solubilize extract 9. Sesame seed oil 6 % Oily phase, Ant arthritic activity 10. Methyl paraben 0.18 % Preservative 11. Propyl paraben 0.02 % Preservative 12. Deionized Water Q.S. Vehicle 14
  • 15. Method of Formulation Step 1 : Formulation of gel : Weighed quantity of Carbopol Dispersed in required quantity of deionized water Stirred at 1500 - 2000 rpm using Mechanical stirrer Add Triethanolamine to adjust pH 6.0 to 6.5 Gel 15
  • 16. Step 2 : Formulation of Emulsion 16 Oil Phase Aqueous Phase Aqueous Phase added to Oil Phase by gentle stirring Cool to room temperature Emulsion
  • 17. Step 3: Formulation of Emulgel : 17 Gel Emulsion Mixed in 1:1 with stirring Emulgel
  • 18. EVALUATION TESTS Physical Parameters: 1. Color 2. Homogenicity 3. Consistency 4. Grittiness 5. Phase separation. pH Viscosity Spreadability Drug content Extrudability study 18
  • 19. EVALUATION TESTS Swelling Index In Vitro diffusion study Stability study 19
  • 20. RESULT AND DISCUSSION  In vitro Diffusion Study: 20
  • 21. REFERENCES 1.American College of Rheumatology. (2012). Rheumatoid Arthritis (1st ed.). Atlanta, DC: Author. 2.Ranade, S.Y & Gaud, R.S. (2013). Current strategies in herbal drug delivery for arthritis: an overview. International Journal of Pharmaceutical Science and Research, 4(10), 3782-3794. 3.Saroha, K. et al. (2013). Transdermal gels - an alternative vehicle for drug delivery. International Journal of Pharmaceutical, Chemical and Biological Sciences, 3(3), 495-503. 4.Singla, V. et al. (2012). Emulgel: A New Platform for Topical Drug Delivery. International Journal of Pharma and Bio Sciences, 3(1), 485-498. 5.Kute, S.B. (2013). Emulsified gel A Novel approach for delivery of hydrophobic drugs: An overview. Journal of Advanced Pharmacy Education & Research, 3(4), 368-376. 6.Rasool, M & Varalakshmi, P. (2006). Immunomodulatory role of Withania somnifera root powder on experimental induced inflammation: An in vivo and in vitro study. Vascular Pharmacology, 44(6), 406- 410. Retrieved 1 December, 2014, from http://www.sciencedirect.com/science/article/pii/S1537189106000747 21
  • 22. REFERENCES 7.Agrawal et al.. (1999). Studies on immunomodulatory activity of Withania somnifera (Ashwagandha) extracts in experimental immune inflammation. Journal of Ethnopharmacology, 67(1), 27-35. Retrieved 1 December, 2014, from http://www.sciencedirect.com/science/article/pii/S0378874199000653 8.Verma, S.K & Kumar, A. (2011). Therapeutic uses of withania somnifera (ashwagandha) with a note on withanolides and its pharmacological actions. Asian Journal of Pharmaceutical and Clinical Research, 4(1), 1-4. 9.Kumar et al. (2015). Efficacy & safety evaluation of Ayurvedic treatment (Ashwagandha powder & Sidh Makardhwaj) in rheumatoid arthritis patients: a pilot prospective study. Indian J Med Res, 141(1), 100-106. 10.Sumantran et al. (2007). Chondroprotective potential of root extracts of Withania somnifera in osteoarthritis. Journal of Bioscience, 32(2), 299–307. 11.Goyal et al. (2011). Novel Anti-Inflammatory Topical Herbal Gels Containing Withania somnifera and Boswellia serrata. International Journal of Pharmaceutical & Biological Archives, 2(4), 1087-1094. 22
  • 23. REFERENCES 12.Anwar, E & Ramadon, D. (2014). Formulation and evaluation of gel and emulgel of chili extract (capsicum frutescens) as topical dosage forms.International Journal of Pharmacy and Pharmaceutical Sciences, 6(3), 13-16. 13.Marwaha, T.K. (2013). Formulation,Design and Evaluation of Herbal Anti-psoriatic Emulgel . Journal of Pharmaceutical & Scientific innovation, 2(3), 30-42. 14.Patil et al. (2014). Novel cosmeceutical herbal emulgel for skin care. World Journal of Pharmacy and Pharmaceutical Sciences, 3(4), 801-811. 15.Mohammed, H.K.P & Nayar, C. (2014). Formulation and Evaluation of Herbal Emulgel of Pothos scandens Linn for Burn Wound Healing Activity. Journal of Pharmaceutical Science & Research, 6(2), 63-67. 16.Oswal, T. & Naik, S. (2014). Formulation and evaluation of mefenamic acid emulgel. International Journal of Pharmaceutical Research and Development, 5(12), 91-100. 23
  • 24. REFERENCES 17.The Ayurvedic Pharmacopoeia India. Government of India Ministry of Health And Family Welfare, Department of Ayush, 1(1). 18.(2006). Carbomer, Ethyl Paraben, Methyl Paraben, Menthol, Propylene Glycol, Thymol. In Rowe, R.C & Sheskey, P.J (Eds), Handbook of Pharmaceutical Excipients (pp. 111-115,287-288,459- 461,624-626,780-781). USA: The Pharmaceutical Press. 19.Dasgupta, P & De, A. (2012). Comparative Standardization Study of Two Marketed Ashwagandha Churna Formulation. International Journal of Research in Pharmaceutical and Biomedical Sciences, 3(2), 734-741. 20.ICH harmonised tripartite guideline (27 october 1994) Validation of analytical procedure. Text and methodology Q2 (R1) current step 4 version parent guidlines. 21.Indian pharmacopeia, (2010). The Indian Pharmacopeia Commission, 1, 37-48. 24
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