This document discusses the development of Withania somnifera-phospholipid complexes to improve the solubility and bioavailability of Withania somnifera. It provides background on Withania somnifera and phospholipid complexes. The plan of work involves preformulation studies, formulation of Withania-phospholipid complexes, characterization studies, in vitro drug release studies, and evaluation of the formulation. Literature on previous phospholipid complex formulations and studies on Withania somnifera are also reviewed. The overall aim is to develop a lipid-based drug delivery system to address the poor solubility of Withania somnifera compounds.

1. PREPARATION AND CHARACTERIZATION OF
WITHANIA SOMNIFERA-PHOSPHOLIPID
COMPLEXES
GUIDE-
Ms. URMI CHAURASIA
PROJECT SUPERVISOR
Dr. A.K DWIVEDI
CHIEF SCIENTIST
DIV. OF PHARMACEUTICS
CSIR-CDRI
PRESENTED BY-
ISHA BHARDWAJ

2. CONTENT
INTRODUCTION
RATIONALE
DRUG PROFILE
LITERATURE REVIEW
PLAN OF WORK
REFERENCES

3. 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.

4. MEDICINAL USES OF WITHANIA SOMNIFERA
STRENGTH VITALITY
POWER
ANTI-CANCER
ANTI-ULCER
SLEEP
RELAXATION
STRESS
DIGESTION
APHRODISIAC

5. 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.

6. IMPROVES SOLUBILITY
FACILITATE MEMBRANE PERMIABILITY
LIPID PROFILE IMPROVEMENT
REDUCED DOSE
HEPATOPROTECTIVE
MODIFIED RELEASE PROFILE

7. 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.

8. DRUG
+
SOLVENT
LIPID
+
SOLVENT
REFLUX FOR 2
HOURS
EVAPORATION
USING
ROTAVAPOR
COMPLEX WILL
BE FORMED

9. Scientific name Withania somnifera
dunal
Common name Ashwagandha , Indian
ginseng
Family Solanaceae
Chemistry More than 40
withanolides , 12
alkaloids and several
sitoindosides have
been isolated.
Main chemical
constituents
Withaferin A ,
Withanolide D ,
Withanolide A ,
12deoxywithastramono
lide
Uses Excellent source of
antioxidants
Classified as adaptogen

10. 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

11.  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.

12. 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.

13.  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

14.  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.