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Ayurveda cam herbal drug development august
1. 11 th world Drug Delivery and Pharmaceutics conference
Ayurveda CAM Herbal Drug-New Products
Development, August 5-2017
Prof. Dr. G.S. LAVEKAR
FORMER Director General, CCRAS
Ministry of AYUSH, Govt. of India
2. Ayurveda CAM Herbal Drug –New Products Development.
Herbal or Ayurveda Drug Development / New Products Development is most essential
and continuous progressive process.
Ayurveda Drug Development is different than the Chemical –Allopathic Drug
Development in many aspects. Like
• World wide Community acceptance and Benefits are more
• Nature Friendly
• Efficacious in life style related chronic diseases
• Minimal side effects, in some cases side benefits are observed
• Time period is very less from Plant to Products
• Total Cost -economical
• Chances of Success are more
• High Ancient treasure of experiential (Observational) knowledge, Ethno botanical
information
• Approval time less and in some new products are treated as health supplements.
3. Developing Chemical Medicines-Drugs is a Risky
Proposition
• It takes $2.6 billion on average to develop a medicine
• It takes an average of 12 years for an experimental drug to
travel from the laboratory to your medicine cabinet
• Chances for success are less than 10 percent
• Only 5 in 5,000 compounds that enter preclinical testing
advance to human testing
• Only 1 of those 5 compounds tested in people is approved
by the FDA
• Just 2 in 10 FDA-approved medicines produce revenues that
exceed average investment
4. Ayurveda, Herbal Natural New products
• Natural Herbal products have been an integral part of the ancient
traditional medicine systems in particular Ayurveda.
• The uses of natural material, especially plants, for healing is as
ancient and universal as medicine itself.
• The therapeutic use of plants certainly goes back to the Vedic
period some four to five thousand B.C.
• In Ayurveda Classical ancient books, listed approximately 1200
different plant species for medicinal purposes.
• More than eight to nine thousand Classical drugs are described in
different ancient and medieval Ayurveda books.
4
5. • Natural products are products from various natural sources, plants,
minerals, marine material, metals and animals.
• Natural products can be an entire plant or different parts of plants
like stem, roots, leaves, gum, resin, flowers etc., an extract of plant,
an organism or part of an organism in processed form.
• World Health Organization (WHO), some 3.4 billion people in the
developing world depend on plant based traditional medicines. This
represents about 88 per cent of the world’s inhabitants, who rely
mainly on traditional medicine for their primary health care.
6. SOURCES OF AYURVEDIC- CAM / NATURAL MEDICINES
(Single and Compound Formulations)
• Plants : 90-95 %
• Minerals : 1-2 %
• Metals : 1-2 %
• Animal Products : 1-2 %
• Marine Products : 1-2 %
These are used in single and multiple ingredients formulations, most of the
formulations are Poly-herbal in nature. Ayurvedic Formulary is the biggest
among the Traditional Medicine consisting of more than one hundred
thousand Formulations
8. Problem of One Vs Several Chemicals
• While many drugs have originated from biologically active plant chemicals, and many
plants, medicine uses can be attributed to various active chemicals found in them, there is
a distinct difference between using a medicinal plant and a chemical drug.
• Drugs usually consist of a single chemical, whereas medicinal plants can contain 400 or
more chemicals.
• It’s relatively easy to figure out the activity and side effects of a single chemical.
• Many Chemical Drugs are derived from different plant sources like..
21. Drug Delivery Routes Dosage Forms
Oral Tablets, Pills, Liquids, Oils, Ghrita, Prash etc.
Trans Dermal Oils, Lepa, Ubtan etc.
Trans Mucosal Oil Pulling, Paste etc.
Per Rectal Enematas
Per Nasal Nasya
Per Ophalmic Netra Bindu, Varti etc.
Inhalation Dhuma
Per Urethral Utter Basti
Per Vaginal Varti,
Direct through Tissues Avchurnan
Through Scalp-Fontenelle Oil, Milk
Drug Delivery Routes and Drug Dosage Forms
23. WITH EACH ERA THE QUALITIES IN NATURE GETS
DECLINED BY ONE FOURTH AND SAME REFLECTS
IN LIVING AND NON LIVING MATERIAL DECLINING
THEIR QUALITIES SLOWLY…
Change is the Universal Law and is a continuous process
Nature means change
24. Necessity of Ayurveda Herbal Drug Development*
Environment Pollution affects
•Water Pollution
•Air Pollution
•Soil Pollution
•Thermal Pollution
•Radioactive Pollution
•Noise Pollution
• Light Pollution
All this reflects in Flora and Fauna due to Gene mutations.
Health-all creatures
25. Apart from this
• Technological progress
Biotechnology
Herbal technology
Information technology (Bioinformatics)
Nano Technology
• Needs are changing
• Change in approach and thinking
26. • There are at least 2,50,000 species of higher
plants that exist on this planet, but merely
five to 10 per cent of these terrestrial plants
have been investigated so far.
• In addition, re-investigation of previously
investigated plants has continued to produce
new bioactive compounds that have the
potential for being developed as drugs.
27. NAMTAH ANUKTA DRAVYA
Many plants are exotic in nature but
domesticated in India like …….
• Glycine max Soyabeen
• Ginko biloba Maidan hair tree / Smritiprada
• Mentha aquatica Water mint / Jala pudina
• Terminalia tomentosa Tomato
• Tylophora asthamatica Ajadveshi
• Ananas cosmosus Pineapple
28. New Properties of Plants / Phytochemical
•Curcumma longa in Alzheimer's disease
•Piper longum as ‘Yogavahi’ – enhances bio availability &
enhancing shelf life
•Vitex negundo in Bronchitis
•Solanum xynthocarpum in Vitiligo
•Wringhtia tinctoria in Psoriasis
•Terminalia chebula as antiatherosclerotic
29. Ayurveda Herbal Drug New Natural product drug
Development
There are two ways
i) The Traditional ways-2
ii). The Modern processes-Marker Identification
30. Sanyoga = Addition / Combination
Vishlesha = Analysis / Separation / Isolation
Kala = Time / Season
Samskara = Treatment
Yukti = Experiment / Pre-Clinical /Clinical Trials
Revalidation / New Product Development strategy
31. The Traditional way
• In the traditional, method of drug discovery from natural
products, drug targets are exposed to crude extracts, and in the
case of a hit, i.e. any evidence of activity, the extract is
fractionated and the active compound is isolated and identified.
• Every step of fractionation and isolation is usually guided by
bioassays, and the process is called bioassay-guided isolation.
32. Types of Natural products
• According to the sources and applications of Natural products, it
can be classified based on their chemical nature as under,
i). Alkaloids
ii). Carbohydrates
iii). Glycosides
iv). Terpenoids
v). Steroids
vi). Phenolics
32
33. Reverse pharmacology and Concept of efficacy evaluation of Susruta
Susrutha has evolved a rational approach of screening the efficacy of therapies the encompass
-Identification of drug based on classical leads (talingatwatt)
-treating the condition with the based on the leads (dristaphalatwatt)
-conformation of efficacy comparing with textual reference (agamaccha)
RVERSE PHARMACOLOGY –
A NOVEL CONCEPT FOR VALIDATION OF TRADITIONAL MEDICINE
This is a novel method of validating the traditional medicines/ formulations cited in classical
literatures of codified systems or drugs/ claims for which the literature on it prolonged clinical use
/safety is available viz . Published documents / folk-lore claims recorded documentation of oral
evidences / practices and so on.
Direct phase II or PHASE-III studies may be initiated after standardization and limited toxicity studies
if required . (simultaneously)
RVERSE PHARMACOLOGY
34. CLINICAL Observations of some Selected Cases
Filarial Chronic Lymphatic Obstructive Edema
Alopecia Areata
Vitiligo
Melasma
Versicolor
Keratosis
Psoriasis
Gall Bladder Stone
Kidney Stone
Uterine Fibroid
39. AYUSH FACE PACK FOR MELASMA
Findings
-The result was assessed using Melasma. Area & Severity
Index (MASI score) (n=20).
-The response was statistically significant with P< . 05. the
average score was 7.32 compared with 19.25
pretreatment score. No side effect was recorded in all
the treated patients.
Before treatment After treatment
58. CONCLUSION
• Dosage-Tab Psoriasis-1 BD,Cap Ashwagandha 500mg at bed time,Oil
application twice daily
• Improvement in Itching and scaling starts after 1 month
64. CASE-5
He is taking med with plain water in morning and with rice water at night,
getting as such no improvement.
65. CASE-6
Case 6 did not follow regime nproperly, as he usually travels,
but initially he followed protocols properly then got results
66. Conclusion
• This treatment should be taken with adviced vehicle to get desirable
results
• To get better results use gluten free diet
• Taking treatment minimum for 3 months is mandatory
• Points of interest-
a. Improvement in frequency and consistency of stool after 1 week
b. Improvement in appetite and sleep observed with the treatment
c. Improvement in abdominal pain, mucous, gas also observed
68. CASE-1
• Mr R-
55yrs,T2DM-15yrs
Duration of treatment-4 months
Observations-
1.Before starting the treatment duration of intercourse was less than a minute
which increases to 5-7 mins after 28 days, further increases to 9 mins after 2nd
batch. Now after 3.5 months his duration of intercourse reached to 10 mins
without feeling lethargic after sex.
2.Libido has increased to such level that he can go for sexual intercourse twice in
a day which was low before starting the treatment.
3.Satisfaction among both partners is much high.
4. Good energy levels after treatment
5.Increase in size and girth of penis as observed by volunteer.
6. Being Diabetic his BSL doesn't shoot up ,i.e BSL F-100,PP-125 during treatment
69. CASE-2
• Mr S-
33yrs, T2DM-1yr
Duration of treatment-1 month 6 days
Observations-
1.Before starting the treatment duration of intercourse is 2-3 mins,no change
observed in 18 days,changes observed after 18 days i.e-Improvement in
erection, duration 4-5 mins in first attempt , 10-15 mins in 2nd attempt.
2. Increase in libido -almost 30%
3. Good energy levels with improved erection
4. Improved satisfaction
5. Before starting the treatment BSL was F-96/98, PP-less than 140, after starting
the treatment BSL shoot upto-107,PP-167-204, now current BSL ,
F-109,PP-140.
70. CASE-3
Mr V
21yrs, PME-7-8 months, No other medical history
Duration of treatment-2 months
Observations-
1.Before starting the treatment duration of intercourse was 5-7 minutes, but his
main concern was early discharge with less satisfaction, he got 10% or mild
improvement after 20 days. After 2 months % of improvement is around 60%.
Duration of intercourse remains the same but he felt more energetic.
2. Improvement in libido
3. Satisfaction among partners is high
4. Increase in size n girth of penis
5. Improvement in energy levels
71. CASE-4
• Mr R-
44yrs
Complaints-Weakness,semenuria-10-12 yrs,constipation,PME,O.A Left knee
Duration of treatment-2 months
Observations-
1.He has severe weakness,with semenuria since 10-12 yrs, started feeling
improvement after 15 days, but that was very little improvement.Improvement
in duration of intercourse was also observed.
2.Little Increase (10-20%)in libido
3. Improvement in energy levels
4. More satisfaction among both partners
72. CASE-5
• Mr Sh
29yrs, Duration of intercourse decreases-2yrs,Early discharge,Size n girth
decreases, Night fall
H/O frequent masturbation
Duration of treatment-2 months
Observations-
1.He observed little improvement after 2 months,as he is not taking the
treatment properly
2.He is taking PME granules and doing massage with ED oil only once in a day
3. Overall improvement he observed is 10-20%.
4. Improvement in energy levels.
73. CONCLUSION
• Dosage of PME granules- 5 gm BD with milk/Water
• Oil massage daily twice to get desirable results
• As per volunteers oil is very effective.
• Duration of treatment min.-3 months
• Consumption of Correct doses is important
75. CONCLUSION
• Method of application of lepa-Clean the area make it dry
• Make a paste and apply externally over the genitals including vaginal opening
• Leave it for overnight then wash in morning
• Precautions to be taken regarding sexual intercourse-3-4 times in a month
(Weekly once)
• Use daily for desirable results
• No itching/irritation/discharge observed after using Lepa=Paste
• Can be used by nullipara as a maintenance therapy.
• Safe in any age group with vaginal muscle loosening.
• Good satisfaction among both partners after using this lepa.
76. S.no Name Age
Medical
problem
Duration Before After Before After Before After Before After Before After Before After
1 25yrs None 6 weeks 67kg 64.6 29 26.5 30.5 26 42 40.5 11 11 21 23
2 58yrs DM,O.A 4 weeks 74kg 70kg 40 38 41 42 45 44 13 12.5 21 23
3 30yrs
None-
Acidity
4 weeks 80 77.4kg 40 38 37 38 42 42 12 12 23 23
4 27yrs None 6 weeks 93/94kg 92kg 41 42 39 39 42 42 15 14 25 25
5 34yrs
Started on
28-Jul-17
77kg 41 40 42 14 22
6 61yrs
O.A/
Thyroid
willgive at
the end of
this month
100kg 41 51 52 15.5 28
BICEPS
WEIGHTLOSS-COMBOPACK
WEIGHT ABDOMEN WAIST HIPS THIGH
78. S.no Age Medical problem Duration Before After Before After Before After Before After Before After Before After Before After
1 47yrs O.A
37 days
/5 weeks
64 60.7 96 94 109.5 102 84 82 112 111 64 60 31 30
2 48yrs
O.A,D.M2
B.P
6 weeks 83.5 78.8 108.4 107 105.4 99 114.3 109.2 116.3 112 63.5 59.6 38.1 38.1
3 None 30 days 98 95
4 50yrs High uric acid 30 days 105 102 111.7 105 129.54 121.9 107.9 104 73.6 63.5 35.5 35.5
5 33yrs
headache n gas
,pain in knees n lowercalf
med-normaxin n nexpro
30 days 88 85 111.7 110 104.1 104.1 109.2 109.2 116.8 114 66 66 35.5 35.5
6 56 None 30 days 87 84.5 101 101 100 100 108 108 101 101 54 54 28 28
7 38yrs Cholescystectomy-8yrs 15 days 70 69 99 99 83.8 83.8 91.4 91.4 114.3 114.3 68.5 68.5 33 33
8 45yrs
GB Stone-1yr,w/d-
watery,smell,m/h-lmp-1-
aug-16,4-5/30,n
flow,painless,thyroid
30 days 74 73 111.7 111.7 106.6 106.6 109.2 109.2 119.3 119.3 60.9 60.9 34.2 34.2
9 O.A 12 days 74 73 106.6 93.9 99 96.5 109.2 111.7 111.7 107 54.6 50.8 33 33
10 24yrs None 15 days 74.5 74 101.6 86.3 91.4 111.7 55.8 30.4
THIGH BICEPS
WEIGHT LOSS-DS
WEIGHT CHEST ABDOMEN WAIST HIPS
79. S.no Name Age
Medical
problem
Duration Before After Before After Before After Before After Before After Before After
1 45yrs None 42 days 77 74 38 36 44 40 46 44 24 22 20 18
2 48yrs
OA,DM
2,B.P
42 days 79 75.9 39 38 43 42 44 43 23.5 23 15 14.5
3 34yrs None
21
days+21
days
97 95.8 44.2 43.4 43 43 22 22 13 12.8
He lost
weight in
last 21
4 54yrs
Arthritis-6
yrs,B.P,Pr
e Diabetic
21 days
107-Early
morning
Empty
stomach/108-
after food
105.8/
106.7
45 42 54 56 55 28 28 16 15.8
5 50yrs None 42 days 102 100 43 41 48 45 41.5 41 25 25 14 13.5
6 46yrs None 21 days 110 110 47 47 50 50 49 49 23 23 17 17
7 48yrs
Diabetes-
20yrs,HT
N-20yrs
2 patients 3 kg
1 1 patient 2 kg
2 2 patients 1 kg
3 1 patient sameComplete evacuation present
THIGH BICEPS
She stopped treatment after 1 week as she was complaining of mouth ulcers and allergy(itching ) at back of neck,b/l upper
and lower limbs after taking medicine
Important Points
Light feeling in body present
No Gastric Issue
WEIGHT LOSS-COMBO PACK
WEIGHT ABDOMEN WAIST HIPS
80. Suggestions..
• QSE –Herbal Ayurveda drugs are efficacious
• Integrative approach- We may develop more safe and efficacious drugs
• There are many Chemical drugs which are Efficacious but Toxic in nature –Type-A-Dose
dependent or Type-B-Idiosyncratic -rare
Mostly toxicity affected organs- Kidney, Liver, Heart, Muscle, Skin etc.
• Antipyretic -Paracetamol –Known Hepato –Toxic
• Anti-Malarial
• Anti -cholesterol
• Antihypertensive
• Consideration of Dietetic Factor
• Vehicle / Bio-Enhancer like Piper nigrum, Cinnamon etc.