PREPARATION AND CHARACTERIZATION OF WITHANIA SOMNIFERA-PHOSPHOLIPID COMPLEXES

GUIDE-Ms. URMI CHAURASIA

PROJECT SUPERVISORDr. A.K DWIVEDICHIEF SCIENTISTDIV. OF PHARMACEUTICSCSIR-CDRI

PRESENTED BY-ISHA BHARDWAJ

CONTENT

INTRODUCTION

RATIONALE

DRUG PROFILE

LITERATURE REVIEW

PLAN OF WORK

REFERENCES

WITHANIA SOMNIFERA

One of the most powerful medicinal plants ,has been used for than 3000 years.Also known as Indian ginseng , Ashwagandha , winter cherry .Possess various medicinal properties.

MEDICINAL USES OF WITHANIA SOMNIFERA

STRENGTH VITALITY

POWER

ANTI-CANCER

ANTI-ULCER

SLEEP

RELAXATION

STRESS

DIGESTION

APHRODISIAC

LIPID BASED DRUG DELIVERY SYSTEM

A novel approach for enhancing oral bio-availability.Lipids, as carriers, used for drug delivery for poorly soluble drugs.Methods – solubilization, encapsulation, complexation etc. examples of some LBDDS- Liposomes , Phytosomes , phospholipid complexes , solid lipid nano particles etc.

PHOSPHOLIPID COMPLEXES

Technique was first developed in Italy in 1989.Involves the complexation of drug with phospholipids. such complexes leads to improved dissolution and bioavailability of a poorly water soluble drug.

What are phospholipids ? a class of lipids that are the component of all cell membranes as they can form lipid bilayer.Amphipathic character.Composition – 2 fatty acids + glycerol unit + phosphate group + polar molecule.

IMPROVES SOLUBILITY

FACILITATE MEMBRANE PERMIABILITY

LIPID PROFILE IMPROVEMENT

REDUCED DOSE

HEPATOPROTECTIVE

MODIFIED RELEASE PROFILE

the aim of the current work is to develop a lipid based drug delivery system to overcome the limitation of poor solubility and bio-availability of poorly solublizing drug candidate Withania Somnifera root and leaf extract thus formulated as w.somnifera complexes...

PREFORMULATION STUDIES - solubility, partition coefficient , melting point etc and selection of analytical methods.

Formulation of Withania-somnifera Phospholipid Complex.

Improving the pharmaceutical properties of drug like solubility, membrane permeability and partition coefficient.

Enhancing bioavailability and activity of drug.

Evaluation of the formulation.

DRUG

+

SOLVENT

LIPID

+

SOLVENT

REFLUX FOR 2 HOURS

EVAPORATION USING

ROTAVAPOR

COMPLEX WILL BE FORMED

Scientific name Withania somnifera dunal

Common name Ashwagandha , Indianginseng

Family Solanaceae

Chemistry More than 40 withanolides , 12 alkaloids and several sitoindosides have been isolated.

Main chemical constituents

Withaferin A ,Withanolide D , Withanolide A , 12deoxywithastramonolide

Uses Excellent source of antioxidantsClassified as adaptogen

THIRD SEMESTER FOURTH SEMESTER

LITERATURE REVIEW•Books•journals

CHARACTERIZATION•Drug content•Zeta potential

PRE-FORMULATION STUDIES•Solubility•Partition coefficient

SURFACE MORPHOLOGICAL STUDIES•TEM

OPTIMIZATION •To check different possible ratios

IN VITRO DRUG RELEASE STUDY

HPLC METHOD DEVELOPMENT COMPATIBILITY STUDIES•FTIR•DSC

Singh D et al (2012) developed an innovative technique in NDDS by developing an amphiphillic phyto phospholipids complex in order to enhance the delivery of poorly soluble rutin. The antioxidant test was carried out and indicated that the bio-activity of rutin was maintained even after being complexed with phospholipids.

X long et al (2014) formulated a combination of phospholipid complex and self emulsifying drug delivery system of baicalin (BCS class IV drug). The synergistic effect resulted in increased solubility, partition coefficient and bioavailablity of baicalin.

Kuntal maiti et al (2006) formulated curcumin phospholipid complexes to overcome the limitation of absorption and to investigate its protective effect on carbon tetra chloride induced acute liver damage in rats.

Arundhati . A Aphale et al (1998) planned a study to access the safety of the combination of Withania Somnifera and Panax Ginseng by doing subacute toxicity studies in rats with 90 days oral administration using 3 doses. It did not revealed any toxicity.

Ahmad et al (2014) carried out stability indicating studies of W.Somnifera including Forced degradation studies, Photo degradation studies, Drug excipient studies. The present studies resulted in the successful development and validation of rapid iso-cratic method for the detection and estimation of withanolide.

Husch et al (2011) recently reported so called NSAID phospholipid complexes in literature to reduce local gastrointestinal toxicity.the present work was dedicated to the structural characterization of so called drug phospholipid complex on the example of diclofenac sodium ibuprofen and piroxicam complexes with dipalmitoylphosphatydylcholine at different stages of preparation.

Maiti, K., et al., Curcumin–phospholipid complex: Preparation, therapeutic

evaluation and pharmacokinetic study in rats. International Journal of

Pharmaceutics, 2007. 330(1–2): p. 155-163

Singh .D et al., Rutin phospholipid complexes: An innovation technique in

Novel Drug Delivery System. Pubmed.gov, 2012 may;9 (3):305-14

Semalty . A et al., Development and characterization of aspirin phospholipid complexes for improved drug delivery; International journal of pharmaceutical sciences and nanotechnology, 2010.3(2):p940-947

Arundhati A. Aphale et al., subacute toxicity study of the combination of Panax ginseng and Withania Somnifera in rats; A safety assessment; Indian J physiology pharmacol 1998;42(2):299-302

Husch.J et al , structural properties of so called NSAID-phospholipids complexes,

European journal of pharmaceutical science,2011,volume44,issue-2,103-116

Devi P U et.al., study of anti-tumor and radio sensitizing properties of Lithuania Somnifera,Indian journal of experimental biology,1996, 34(10):927-932.

Singh.G, Sharma.P, Dudhe.R Reviewed., Biological activity of Withania Somnifera, Annals of biological research, 2010,1(3):56-63.

Withania somnifera(L.) USDA,NRCS.2007. The PLANTS database (http;\\plants.usda.gov), 2010.