COMPARATIVE ESTIMATION OF PIPERINE IN AYURVEDIC LOZENGES BY UV SPECTROSCOPIC METHOD.

ISBN: 978-81-85694-67-2

Abstract

Ayurvedic lozenges are immensely popular in today’s world, because due to its highly palatable taste, cheap, soothing effect, counter-irritant effect, decreasing abdominal flatulence, and treating Anorexia. Herbs of Piper species are one of the most important ingredients of Ayurvedic lozenges and Piperine is the main chemical constituent of herbs of Piper species. In the present study an attempt was made for the estimation of piperine in ayurvedic lozenges sample by using UV-spectrophotometer. Three samples of lozenges from different reputed brand have been selected for this purpose. The amount of piperine in three samples (S-1, S-2, and S-3) was found to be 1.55, 1.36 and 1.40 µg/ml respectively. Recovery studies were carried out by standard addition method and the average % recovery of the three samples S-1, S-2, S-3 were found to be 98.62%, 99.32%, and 98.35% respectively.

Introduction

Lozenges are small, medicated candy intended to be dissolved slowly in the mouth to lubricate and soothe irritated tissues of the throat and also have carminative effect. Several ayurvedic companies come forward in today’s FMCG field to market throat lozenges, and carminative digestive lozenges. Trikatu^[1-3] is an important ayurvedic formulation, which have synergistic effect, and is used in several classical anti-tussive, expectorant^[2] preparation and also to fight, acidity^[3] and anorexia. Trikatu consists of Piper longum, Piper nigrum and Zingiber officinalis^[4]. Piperine is an important heterocyclic alkaloid of pyridine and piperidine skeletal structures ^[4] found in the herbs of Piper species. These herbs enhanced the activities of antioxidant enzymes--superoxide dismutase, catalase, glutathione reductase and glutathione-S-transferase in both gastric and intestinal mucosa, suggesting a gastrointestinal protective role which is the main responsible factor for the therapeutic effect of these ayurvedic lozenges. Apart from the classical use, recent study has proved that Piperine have antidepressant activity ^[5-6], anti-inflammatory activity^[7], gastro protective effect^[8-9], immune-modulator effect^[10], bioavailability enhancer^[11] etc. Hence the amount of piperine in this type of lozenges may be a parameter, to determine the quality of ayurvedic lozenges. In the present study a comparative evaluation of the three most popular branded ayurvedic lozenges on the basis of Piperine content.

MOLECULAR Wt	285.342
MOLECULAR FORMULA-	C17H19NO3

Materials and methods

Gift sample of Piperine standard was taken from Merck chemicals, India. Ayurvedic lozenges from three different brands were collected from local vendor, and named them as S-1, S-2 and S-3. UV absorbance was recorded using “Varian UV- Spectrophotometer” with Carry-100 software.

Preparation of standard solution for calibration curve of ciprofloxacin

Stock solution of Piperine was prepared by dissolving 0.01gram in 10 ml of methanol. Standard solutions were prepared from stock solution in the range of 2 to 20 µg/ml in methanol. The absorbance of piperine was measured at 342 nm (λ_max for piperine) against water as blank. Mean of three readings were taken for each standard solutions. Calibration curve was plotted between absorbance and concentration. 

Table1: Standard curve of Piperine

Standard	Conc. (µg/ml)	Mean*	SD	%RSD
Std. 1	0.0	0.0005	0.0007	>100
Std. 2	2.0	0.1150	0.0003	0.26
Std. 3	4.0	0.2375	0.0006	0.24
Std. 4	8.0	0.5258	0.0007	0.13
Std. 5	12.0	0.8425	0.0000	0.00
Std. 6	16.0	1.1795	0.0004	0.03
Std. 7	20.0	1.5454	0.0006	0.04

   *Value expressed as mean of three readings

Preparation of sample solution

Five lozenges of S-1 were taken in a mortar and pestle, and powdered. The powdered sample was dissolved in the water q.s, and then chloroform is added to the water containing the dissolved sample. The bi-phasic mixture is then taken in a separating funnel and slowly shaken. The chloroform part which contains piperine is separated out, the chloroform is evaporated in water bath, and TLC is carried out with the piperine extract, for its conformation, with the application of standard Piperine spot, on the same plate. Then methanol is added to the piperine extract, and the solution is diluted. The mobile phase is made up of chloroform and methanol in the ratio of (95:5), the absorbance of sample solutions was measured at 342 nm against methanol as blank. Mean of three readings were taken for each sample solutions, the process was repeated with the sample, S-2 and S-3.   

   

Sample	Conc. (µg/ml)*	SD	%RSD
S1	1.55	0.0003	0.24
S2	1.36	0.0002	0.19
S3	1.40	0.0002	0.21

Results and discussion.

This method involves the measurement of UV absorbance at 342 nm for piperine corresponding to the absorption maxima. The absorbance characteristics showed that piperine obeys Beer’s Lambert law within the concentration range from 2-20 µg/ml at the λ_max 342 nm. Calibration equation for this method was found to be Abs = 0.07733*Concentration, with Correlation Coefficient is of 0.99569.                                                               

Recovery Studies were carried out by standard addition method & the average % recovery of the four samples S1, S2 and S3 were found to be 98.62%, 99.32% and 98.35 % respectively. Results obtain from the recovery study indicating the accuracy & the precision of the method.

Conclusion

The developed method was found to be accurate & simple. We came to know that all the three samples of lozenges from different manufacturers contains considerably amount of piperine, and thus they bear the necessary quality, for therapeutic efficacy.

References

1. Kaviraj Kunjalal Bhisagratna. Susruta Samhita , 38/58-19, Chowkhamba Sanskrit Series Office. Third Edition. 2005

2. K.R. Srikantha Murthy. Bhavaprakasa of Bhavamisra . Chowkhamba Sanskrit Office.

3. S. Suresh Babu .Yoga Ratnākara. Chowkhamba Sanskrit Series Office. Third Edition

4.Trease & Evans. Pharmacognosy. Elsevier publication.Fifteenth edition, p 335

5. Pal A, Nayak S, Sahu PK, Swain. Piperine protects epilepsy associated depression. A study on role of monoamines. Eur Rev Med Pharmacol Sci 2011; 15(11):1288-95

6. Mao QQ, Huang Z, Ip SP, Xian YF, Che CT. Role of 5-HT(1A) and 5-HT(1B) receptors in the antidepressant-like effect of piperine in the forced swim test. Neurosci Lett. 2011;504(2):181-4.

7. Sabina EP, Nagar S, Rasool. M.A role of piperine on monosodium urate crystal-induced inflammation--an experimental model of gouty arthritis.Inflammation 2011 Jun;34(3):184-92.

8. Prakash UN, Srinivasan K. Gastrointestinal protective effect of dietary spices during ethanol-induced oxidant stress in experimental rats.Appl Physiol Nutr Metab 2010 Apr;35(2):134-41

9.Ramakrishna Rao R, Platel K, Srinivasan K. In vitro influence of spices and spice-active principles on digestive enzymes of rat pancreas and small intestine. Nahrung 2003 Dec;47(6):408-12.

10.Pathak N, Khandelwal S. Immunomodulatory role of piperine in cadmium induced thymic atrophy and splenomegaly in mice.Environ Toxicol Pharmacol  2009 Jul;28(1):52-60

11.Atal CK, Dubey RK, Singh J. Biochemical basis of enhanced drug bioavailability by piperine: evidence that piperine is a potent inhibitor of drug metabolism. J. Pharmacol. Exp. Ther; 232(1): 258–62. 

A REVIEW ON CURRENT TRENDS IN PHARMACEUTICAL MARKETING OF AYURVEDIC DRUGS

ISBN NO.- 978-93-81212-11-0

ABSTRACT:
The pharmaceutical industry is the world’s largest industry due to worldwide revenues of approximately US$2.8 trillion. Ayurvedic Pharma companies have some little contribution to that but it is very important, & growing very faster too. Now a days, & in recent future Herbal/Ayurvedic companies will take a very big part in the pharma industry. India played a major role in that area. Many countries from Asia, like Chaina, Japan etc. are also leading contributors. USA, Europe are playes roles mostly as consumers. However the marketing of those products are also important. Because marketing is the key for any pharma company for growing & achieving the desired success. So for that different companies adopt different strategies & implement them on practical field.

1.Introduction:
Indian Pharmaceutical Industry is poised for high consistent growth over the next few years, driven by a multitude of factors. Top Indian Companies like Ranbaxy, DRL CIPLA, Himalaya and Dabur have already established their presence.
The Indian pharmaceutical industry came into existence in 1901, when Bengal Chemical & Pharmaceutical Company started its maiden operation in Calcutta.

2. Transforming Ayurveda1
The Indian Ayurvedic industry is re-packaging the Traditional healing principles into a modern avatar. Before the evolution of Indian Ayurveda into an industry, the practice of Ayurveda was confined to physicians and was considered more of a service than a profession

3. Pharma Marketing Process and its Challenges2
Many pharmaceutical companies have successfully deployed plethora of strategies. Use of medical representatives for marketing products to physicians and to exert some influence over others in the hierarchy of decision makers has been a time-tested tradition. Typically, sales force expense comprises an estimated 15-20% of annual product revenues, the largest line item on the balance sheet.
Most Prominent Performance Related Issues:

a) Increased competition and shortened window of opportunity.
b) The number and the quality of medical representatives
c) Very high territory development costs.
d) High training and re-training costs of sales personnel.
e) Busy doctors giving less time for sales calls.
f) Poor territory knowledge in terms of business value at medical representative.

4. Pharmaceutical Company Business Strategies3
What’s the secret behind these successes? For one, the company operates in niche formulations (chronic) segments such as psychiatry, cardiovascular, gastroentology and neurology. While most of the top Indian companies have focused on antibiotics and anti– infective (acute), Sun Pharma focused on therapeutic areas such as depression, hypertension and cancer. Two models are described for the business strategies of pharmaceutical companies.

4.1 Marketing approaches of Super Core Model
In pharmaceutical market there has been a significant shift from Acute towards Chronic Therapy area. Chronic segments are driving the growth of the market. This is evident from high growth rates achieved by firms like Sun Pharma, Dr.Reddy laboratories and Dabur Pharma Ltd.
Pharmaceutical companies are competing with one another, and might adopt a new sales strategy. For example, sometimes in the same geographical area there are five representatives for just one company, or different representatives for the same drug in different settings. As a result the aggressiveness of representatives has also been increasing. Therefore, they tend to have more frequent visits to encourage doctors to prescribe drugs and thus increase sales.

4.2 Marketing approaches of Core Model
In present scenario companies are focusing more and more on the availability of products so as to enjoy good image in their cutomer’s (doctors) chamber. Many companies such as Glaxo, Pfizer, Dabur, FDC, Aventies, Cipla etc. are known for their availability of products.
It has been observed that sometimes there are more than fifteen or sixteen representatives in a day are meeting with their customer and requesting for same type of products.

5. Global Market4
Total global herbal market is of size 62.0 billion dollars, in this India’s contribution is only one billion dollars. European union is the biggest market with the share 45% of total herbal market. North America accounts for 11%, Japan 16%, Asian countries 19% and rest of European Union 4.1%. Countries like Japan and China have successfully marketed their traditional medicines abroad.
When compared to the Chinese and the Japanese level of penetration in the global market India is not at all figuring anywhere. India has 16 Agro-climatic zones, 10 vegetative zones, 15 biotic provinces, 426 biomes, 45000 different plant species and 15000 medicinal plants that include 7000 ayurveda, 700 in Unani medicine, 600 in Siddha medicine and 30 in modern medicine. This makes India one among 12 mega biodiverse countries of the world, which despite having only 2.5 % total land area, accounting for over 8 % of the recorded species of the world. The forecast is that the global market for herbal products is expected to be $5 Trillion by 2050.

6. Regulatory Status of Herbal Medicine Worldwide5
The World Health Organization (WHO) estimates that 4 billion people—80 percent of the world population--use herbal medicine for some aspect of primary health care. Herbal medicine is a major component in all indigenous peoples' traditional medicine and is a common element in
Ayurvedic, Homeopathic, Naturopathic, traditional oriental and Native American Indian medicine.

6.1 Europe
Drug approval considerations for phytomedicines (medicines from plants) in Europe are the same as those for new drugs in the United States, where drugs are documented for safety, effectiveness, and quality.

6.1.1 France
where traditional medicines can be sold with labeling based on traditional use, requires licensing by the French Licensing Committee and approval by the French Pharmacopoeia Committee. These products are distinguished from approved pharmaceutical drugs by labels stating "Traditionally used for . . .".

6.1.2 Germany
In Germany there is a further distinction between "prescription-only drugs" and "normal prescription drugs." The formers are available only by prescription.

6.1.3 England
England generally follows the rule of prior use, which says that hundreds of years of use with apparent positive effects and no evidence of detrimental side effects are enough evidence that the product is safe.

6.2 Asia:
In more developed Asian countries such as Japan, China, and India, "patent" herbal remedies are composed of dried and powdered of herbs or herb extracts in liquid or tablet form. Liquid extracts are used directly in the form of medicinal syrups, tinctures, cordials, and wines.

6.2.1 China: In China, traditional herbal remedies are still the backbone of medicine. Use varies with region, but most herbs are available throughout China. Until 1984 there was virtually no regulation of pharmaceuticals or herbal preparations. In 1984, the People's Republic implemented the Drug Administration Law.

6.2.2 Japan:
Traditional Japanese medicine, called ‘Kampo’, is similar to and historically derived from Chinese medicine but includes traditional medicines from Japanese Folklore. Today 42.7 percent of Japan's Western-trained medical practitioners prescribe Kampo medicines, and Japanese national health insurance pays for these medicines.

7. THE AYURVEDIC MEDICINE INDUSTRY IN INDIA6
Ayurvedic medicines are produced by several thousand companies in India. The industry has been dominated by less than a dozen major companies for decades.The key suppliers in Ayurveda are Dabur, Baidyanath, and Zandu, which together have about 85% of India's domestic market.
Dabur India Ltd. is India's largest Ayurvedic medicine supplier and the fourth largest producer of FMCG. It was established in 1884, and had grown to a business level in 2003 of about 650 million dollars per year, though only a fraction of that is involved with Ayurvedic medicine.
Sri Baidyanath Ayurvedic Bhawan Ltd. was founded in 1917 in Calcutta, and specializes in Ayurvedic medicines, though it has recently expanded into the FMCG sector. Baidyanath has a sales volume of about 350 million dollars. The company reports having over 700 Ayurvedic products.
Zandu Pharmaceutical Works was incorporated in Bombay in 1919. The company focuses primarily on Ayurvedic products. Today its total sales volume is about 45 million dollars. One of its current projects is to develop a dopamine drug from a plant extract.
The Himalaya Drug Company was established in 1934 in Bangalore. It currently has a business of about 500 million dollars. It is known in the U.S. for the product Liv-52, marketed as a liver protector.
Charak Pharmaceuticals was founded in 1947, and currently has three distribution centers in India. It has gained a large advantage with its new product Evanova.
Vicco Laboratories was established in 1958. It is best known internationally for its toothpaste product, Vajradanti, which has been marketed in the U.S. for more than 25 years.
The Emami Group founded in 1974, provides a diverse range of products, doing 110 million dollars of business annually. The parts, himani & Zandu prepare Ayurvedic preparations.
Aimil Pharmaceuticals Ltd. incorporated in 1984 and engaged in manufacturing and sale of both generic and proprietary Ayurvedic medicines, with a business level of about 20 million dollars annually. It was honored by the Indian Government's National Award for Quality Herbal Preparations and National Award for R & D in the year 2002.


8. STATUS OF AYURVEDA IN INDIA7
The statistics on the Ayurvedic system in India and these data about the manpower and institutional aspects of Ayurveda have emerged:
• Number of registered medical practitioners: 366,812
• Number of dispensaries: 22,100
• Number of hospitals: 2,189
• Number of hospital beds: 33,145
• Number of teaching institutions (undergraduate): 187
• Number of upgraded postgraduate departments: 51
• Number of specialties in postgraduate medical training: 16
• Number of pharmacies manufacturing Ayurvedic medicines: 8,400

9.CONCLUTION
There has been a shift in universal trend from synthetic to herbal medicine recently. It is ancient wisdom that plants have therapeutic value and are used to treat various diseases since Neanderthal age. All ancient civilizations in the world are known to use plants for medicinal purposes. Ayurveda and traditional Chinese medicines are well known to the world for their natural ingredients and multiple benefits. Nature has bestowed our country with an enormous wealth of medicinal plants; therefore India has often been referred to as the Medicinal Garden of the world.
Today, people around the globe are giving preference to alternative medicines such as Ayurveda, Naturopathy, Homeopathy and Herbal Medicine. Increasing realization of the side effects of Allopathic medicines, coupled with the growing awareness about the medicinal benefits as well as therapeutic effect of herbal products is pushing up the demand for herbal extracts, dietary supplements and herbal-based beauty aids worldwide.


10.REFERENCE
1. www.expresspharmaonline.com/20080831/market01.shtml
2.searchengineland.com/getting-to-the-heart-of-things-big-pharma-marketing-challenges-12002
3. www.glgroup.com/News/Pharmaceutical-business-strategy-27029.html
4. http://www.hindu.com/2010/03/24/stories/2010032454380500.htm
5. www.who.int/medicinedocs/pdf/whozip57e/whozip57e
6. www.itmonline.org/arts/ayurind.htm
7. www.ccimindia.org/colleges_status_ayurveda_2010-11.php