This invention relates to herbal anti-inflammatory tablet (OSTRANIL PLUS) COMPOSITION AND METHOD THERE OFF, for the treatment of "Musculoskeletal Disorders, Joint Pains & Spondylitthe treatment of "Musculoskeletal Disorders, Joint Pains & Spondylitis."
The object of the invention is to relive pain and stiffness in joint pains and spondylitis
Another object of the invention is to give permanent cure to Musculoskeletal disorders.
Still another object of the invention is to give safe medicine in order not to have any side effects there by treating the patient completely.
Still another object of the invention is to have the medicine cheap so that it is affordable to a common person.
BACKGROUND OF INVENTION: Prior art and defects:
Diseases of the Musculoskeletal system and connective tissue comprise a heterogeneous group of disorders in which musculoskeletal pain and stiffness are prominent. The most common type of Arthritis, is caused by the breakdown and eventual loss of Cartilage, is a common musculoskeletal disorder. Hence it is also called as degenerative joint disease, or, wear & tear arthritis. Classified as non-inflammatory arthritis, though disputable, damage due to Musculoskeletal disorder (MSD) progresses slowly over time and swelling of joints is usually uncommon in the early stages. The cost of the United States economy attributed to musculoskeletal disorders is more than 20 Billion Dollars per Annum.
Musculoskeletal disorder (MSD) is primarily a disease of cartilage that produces a local tissue response, mechanical change, and failure of function. The tough elastic material, cartilage, covers the ends of the bone in a joint. During course of time, and for pathological reasons, cartilage wear away or bits may break off. When cartilage wears out bones start to rub against each other in the joint while the bits of cartilage that break off disturb the soft tissues. These actions cause pain and swelling leading to difficulty in moving the joints and resulting in nonfunctioning joints. 80% of those with MSD will have limitations in movement, and 25% cannot perform their major daily activities of life (http://www.who.int/chp/topics/rheumatic/en/). Heredity, over weight, joint injury, nutritional deficiency are some key risk factors that promote MSD and hips, knees, feet, spine finger and thumb joints are those usually affected.
Musculoskeletal disorder (MSD) is already one of the ten most disabling diseases in developed countries. Estimated to be the,10th leading cause of non-fatal burden in the world in 1990 and 4th leading cause of YLDs at global level (Murray CJL, Lopez AD. Mortality by Cause for Eight Regions of the World, Global Burden of Disease Study. 1997, World Health Organization. World Health Report 2002. Reducing Risks, Promoting Healthy Life. Geneva: WHO, 2002.) Pain relief and restoring function to the affected joint form the focus of MSD treatment. In a detailed study, patients have reported their expenditure to about 2000 US $ per year in J 999 (THE BURDEN OF MUSCULOSKELETAL CONDITIONS AT THE START OF THE NEW MILLENIUM, WHO Technical Report Series-919, WHO, 2003) indicates that,. Worldwide estimates are that 9.6% of men and 18.0% of women aged over 60 years have symptomatic musculoskeletal disorder. (http://www.who.int/chp/topics/rheumatic/en/). More than 70% of people aged between 55 to 78 have radiographically defined Musculoskeletal disorder [Lawrence RC, Helmick CG, Arnett FC, Deyo RA, Felson DT, Giannini EH, et al. Estimates of the prevalence of arthritis and selected musculoskeletal disorders in the United States. Arthritis and Rheumatism 1998; 41:778-99.].
Musculoskeletal disorder (MSD) affects usually after the age of 40, though it can occur at any age. Though, in males it occurs more frequently before age 40 and in females after age 55, women tends to be more affected than men (Silman AJ, Hochberg MC. "Epidemiology of the rheumatic diseases".~ Oxford: Oxford University Press, 1993, Lawrence JS, Sebo M. "The geography of Musculoskeletal disorder (MSD). In Kent NG, Editor. "Aetiopathogenesis of
Musculoskeletal disorder", London: Pitman Medical; 1980. pg. 155-83.). In addition to variation in sex, there exist geographical and ethnic based variations. Hip musculoskeletal disorder (MSD) seems to be less common in Africa and Asia than in western countries [Brooks PM. "Impact of Musculoskeletal disorder (MSD) on individuals and society : how much disability? Social consequences and health economic implications. Current Opinion in Rheumatology 2002;14:573-7.]. African American females are more prone than Caucasian females to Musculoskeletal disorder (MSD) of the knee (Anderson JJ, reported that, Felson DT. Factors associated with Musculoskeletal disorder (MSD) of the knee in the First National Health and Nutrition Examination Survey: evidence for an association with overweight, race and physical demands of work. American Journal of Epidemiology 1988; 128:179-189) but not for the hip (Tepper S, Hochberg MC. Factors associated with hip musculoskeletal disorder data may be observed, from the First National Health and Nutrition Examination Survey (NHANES-I) of American Journal of Epidemiology 1993; 137(10):1081-1088).
Modern medicine, unfortunately has not found a cure for musculoskeletal disorder, yet. Medications are commonly used to treat MSD, however their status of recommendations are unstable. In 1995 guidelines developed for the American College of Rheumatology simple analgesics like Paracetamol were recommended. However, in a revision in the year 2000 the suggestions were for Non-steroidal Anti-inflammatory Drugs, following most potent preferences (George E. Ehrlich, The rise of MSD, Bulletin of the World Health Organization 2003, 81(9), 630).exhibits, 22.9% of all prescriptions were written for musculo-skeletal disease account, and for musculoskeletal disorder the expenditure are 9% of the total health system Cost (Mathers C, Penm R. "Health system costs of injury, poisoning and musculoskeletal disorders in Australia: 1993-94". Canberra, Australian Institute of Health and Welfare, 1999 (AIHW Catalogue No. HWE12; Health and Welfare Expenditure Series No. 6).)
OBEJCT OF INVENTION
Many medications have been tried and are in use, but research on their effectiveness is lacking (T.P. Stitik and P. M. Foye, in an article, reports on "Musculoskeletal disorder (MSD)", vide, http://emedicine.medscape.com/article/305145-treatment). "The goal of musculoskeletal disorder therapy is to reduce joint pain and inflammation while improving and maintaining joint function." Present medications include simple analgesics like Paracetamol, non-steroidal anti-inflammatory drugs, Cyclo-oxygenase (COX-1 & COX - 2) inhibitors and opioid analgesics.
Paracetamol is the drug of choice for pain. Normal dose is up to 4 gms/day and chances of hepatotoxicity increase with chronic alcoholics and if co-administered drugs includes drugs as barbiturates, ionized.
Non-steroidal anti-inflammatory drugs exhibit analgesic, anti-inflammatory and anti-pyretic activities. Such properties appeal more specially during early stages of MSD, e.g. Ibuprofen upto 3.2 g/day. Adverse GI effects are hard to avoid with NSAIDs and it's a matter of concern when the target patients, are in the elderly group.
COX-2 inhibitors e.g. Celecoxib 400 mg/ day are more selective and avoid COX-1, thereby reducing chances of NSAID induced GI toxicity. However, increased risk of myocardial interaction has been confirmed in many trials (Psaty BM, Furberg CD, COX-2 inhibitors-lessens in drus safety, N Engl J Med. 2005 Mar 17; 352(11): 1133-5).
Opiod analgesics e.g. Oxycodone 5 mg/every 6 hrs, are considered when non opiod analgesics are NSAIDs fail to control pain. However, opiod related mortality is a serious problem. Especially after the 5-fold increase in oxvcodone-related mortality following the prescription of long acting oxycodone (Dhalla IA, Mamdani MM, Sivilotti ML, Kopp A, Qureshi O, Juurlink DN, described, the system of prescribing of opioid analgesics and related mortality before and after the introduction of long-acting oxycodone, vide in, CMAJ. 2009 Dec 8;181(12):891-6). Intraarticular injections are considered in case of severe pain. Steroidal intra-articular injections e.g. glucocorticoids are effective in reducing the pain significantly for a period of 4-6 weeks (Godwin M, Dawes M, Intra-articular steroid injections for painful knees. Systematic review with meta-analysis,
Can Fam Physician. 2004 Feb;50:241-8). But their usage is restricted to not more than 3 injections per year in a site (T.P. Stitik and P. M. Foye, Musculoskeletal disorder (MSD), http://emedicine.medscape.com/article/305145-treatment). Hyaluronic acid is injected intra articularly to help restore viscoelastic and tribolosical properties of synovial fluid. It reduces the pain and improves functionality with effects sustainim up to 12 months. However, there are also systematic reviews and meta analysis that questions the risk-benefit ratio and doubt their clinical effectiveness ( a research study by :Arrich J, Piribauer F, Mad P, Schmid D, Klaushofer K, Milliner M, "Intra-articular Hyaluronic acid for the treatment of Musculoskeletal disorder (MSD) of the knee: systematic review and meta-analysis, CMAJ. 2005 Apr 12; 172(8): 1039-4).
Irrespective of the various drugs applied and those currently under study, none have a disease-modifying effect in humans {Recommendations for the medical management of Musculoskeletal disorder (MSD) of the hip and knee: 2000 update. ( American College of Rheumatology Subcommittee on Musculoskeletal Disorder Guidelines Arthritis Rheum. Sept. 2000:43(9):1905-15.)
Numbers of substances that occur naturally have reported to be of value in the prevention or treatment of musculoskeletal disorder.
Dietary supplements as glucosamine and chondroitin sulfate following their oral administration have been reported to decrease the rate of joint space narrowing (Pavelka K, Gatterova J, Olejarova M, Machacek S, Giacovelli G, Rovati LC, Glucosamine sulfate use and delay of progression of knee Musculoskeletal disorder (MSD): a 3-year, randomized, placebo-controlled, double-blind study, Arch Intern Med. 2002 Oct 14; 162(18):2113-23) and decrease the activity of catabolic enzymes in Osteoarthritic Cartilage ( McAlindon TE, LaValley MP, Gulin JP, Felson DT, Glucosamine and Chondroitin for treatment of Musculoskeletal disorder (MSD): a systematic quality assessment and meta-analysis, JAMA ~2000 Mar 15;283(11): 1469-75.), respectively. However, these agents did not reduce pain effectively either alone or in combination (Clegg DO, Reda DJ, Harris CL, Klein MA, O'Dell JR, Hooper MM, Bradley JD, Bingham CO 3rd, Weisman MH, Jackson CG, Lane
NE, Cush JJ, Moreland LW, Schumacher HR Jr, Oddis CV, Wolfe F, Molitor JA, Yocum DE, Schnitzer TJ, Furst DE, Sawitzke AD, Shi H, Brandt KD, Moskowitz RW, Williams HJ, Glucosamine, Chondroitin Sulfate, and the two in combination for painful knee Musculoskeletal disorder (MSD), N Engl J Med. 2006 Feb 23;354(8):795-808). In addition, generally safe for most people, may be very dangerous to those allergic to shellfish.
Niacinamide is a water soluble vitamin (B3). Intake of niacinamide, 500 mg six times a day has been reported to reduce inflammation and improve joint flexibility in Musculoskeletal disorder (MSD). However, the onset of action was delayed by 3 to 4 weeks and no better effect was observed in pain control than placebos (Jonas WB, Rapoza CP. Blair WF. The effect of niacinamide on Musculoskeletal disorder (MSD): a pilot study, Inflamm Res. 1996 Jul;45(7):330-4). In addition with high doses of niacinamide for prolonged periods, niacinamide induced hepatitis is cautioned, though rare (Scheer MS, Perlmutter S, Ross W.Katz DS, Ultrasonographic findings in niacin-induced hepatitis, J Ultrasound Med. 1999 Apr;18(4):321-3} is furnished, herein..
Vitamin E is a fat soluble vitamin reported to possess anti-inflammatory property (Stuyvesant VW, Jolley WB. Anti-inflammatory activity of d-alpha-tocopherol (vitamin E) and linoleic acid,:Nature 1967;216:585-586). Vitamin E reduces pain ~ (Machtey I, Ouaknine L. Tocopherol in Musculoskeletal disorder (MSD): a controlled pilot study ~ J. Am. Geriatric Soc 19 78:26:328-330), circumference of joints and walking time and increase mobility in Musculoskeletal disorder (MSD) and reported to be equally effective as diclofenac (Scherak O, Kolarz G, Schodl C, Blankenhorn G. " High dosage vitamin E therapy inpatients with activated arthrosis. ZRheumatol 1990; 49:369-373.). However, recent study have reported that vitamin E is ineffective for symptomatic relief of MSD (Brand C, Snaddon J, Bailey M, Cicuttini F, Vitamin E is ineffective for symptomatic relief of knee MSD : a six month double blind, randomized, placebo controlled study, Ann Rheum Dis. 2001 Oct;60(10):946-9).
Sadenosylmethionine (SAMe), a metabolite of the essential amino acid methionine functions as a methyl donor in many biochemical reactions. SAMe has been reported to be as effective as NSAIDs as Naproxen (Caruso I, Pietrogrande V. Italian double-blind multicenter study comparing Sadenosylmethionine, naproxen, and placebo in the treatment of degenerative joint disease. Am J Med 1987;83:66-71.), Piroxicam (Maccagno A, Di Giorgio EE, Caston OL, Sagasta CL. "Double-blind controlled clinical trial of Oral Sadenosylmethionine versus piroxicam in knee MSD". Am J Med 1987;83:72-77.), in the treatment of MSD. But the product is very expensive and stability problems reported that require advanced drug delivery techniques to provided. (Czap A. "Beware the son of SAMe". Altern Med Rev 1999;4:73).
Knowing the side effects of organic remedies and increasing public dissatisfaction with the cost of prescription drugs, patients are in search of complimentary or alternative medicines. WHO estimates that 80% of the people worldwide rely on herbal medicines for some aspect of their primary health care. In 1993, Herbal medicine was found to be used by 3% of the US population (Eisenberg DM. Kessler RC. Foster C, et al: Unconventional medicine in the United States: prevalence, cost, and patterns of use. N Engl J Med 1993; 328:246-252) and the consumption of medicinal botanicals in various forms reported to be rising at a rate of approximately 15% (Borchers AT, Hackman RM. Keen CL. et al: Complementary medicine: a review of immunomodulatory effects of Chinese herbal medicines. Am J Clin Nutr 1997; 66:1303-1312). Some 600 to 700 plant-based remedies are available in Germany, and an estimated 70% of German physicians prescribe phytomedicines. European consumers spent $7 billion on retail herbal remedies in 1996 (half being sold in Germany) (W. Curt LaFrance, Jr., Edward C. Lauterbach, C. Edward Coffey, Stephen P. Salloway, Daniel I. Kaufer, Alison Reeve, Donald R. Royall, Elizabeth Aylward, Teresa A. Rummans, and Mark R. Lovell:: The Use of Herbal
Alternative Medicines in Neuropsychiatry: A Report of the ANPA Committee on Research, J Neuropsychiatry Clin Neurosci, May 2000; 12:177-192.).
Various concerned Ministries/departments of Government of India are actively giving support for research and development in the pharmaceuticals sector including herbal medicines for the development of drugs in chronic diseases like musculoskeletal disorder. As a result, number of projects have been mounted related to research and development for the development of drugs for chronic diseases. As of now, many drugs are available in the market and few new molecules have been developed and are undergoing Phase-I clinical trials. However, the search concentrated on any molecule is aimed at solving a particular symptom /problem. Treatments involving use of active molecules(s) are known to cause drug induced side effects. When the side effects are intolerable, it is common to search for other systems of treatments that can overcome the side effects associated with the specific chemical entity as well as patient noncompliance. In traditional system of medication including Ayurvedic system, multiple drugs in their crude form are to be believed to show remarkable therapeutic effect with little or no side effects. Medication with herbal drugs at present, using the concepts of conventional drug delivery systems such as herbal suppositories (US Patent Appl. 20020031559) and herbal lozenge composition (US Patent Appl. 20060251731) are reported. Herbal medicinal products (HMP's) are also used in a variety of oral and topical forms for treatment of musculoskeletal disorder.
Herbal medicines for Musculoskeletal disorder (MSD):
Because of the severity and complexity, the treatment of musculoskeletal disorder, is often frustrating for patients, families and clinicians. Out of desperations, many patients and families turn to alternative therapies, such as nutrition, herbs and Chinese medicines. Whether they are purified or raw, synthetic or natural, modern or ancient, the herbs and supplements work biochemically - just as standard medicines do. Herbal remedies are a mainstay of ethno botanical medicine worldwide. Cultural remedies that are part of Ayurvedic medicine (the traditional medicine in India) and other traditional healing systems rely heavily on herbs. Whole herbs contain many ingredients, and it is very likel,y that they work together, to produce the desired medicinal effects. Medications using herbs use whole plants /parts of plants, rather than extracting single components from them. Whole plant extracts have many components. These components work together to produce therapeutic effects and thus lessens, the chance of side
effects from any one component. Hence, several herbs are often used together, to enhance effectiveness and synergistic actions and to reduce toxicity.
Hemidesmus Indicus (L.) Schult. (Anantamul)
This plant is used in chronic rheumatism, skin affections and as a blood purifier.
The root of Hemidesmus indicus known as "Indian Sarsaparilla" has long been employed in
Southern India as an alternative tonic.
It is a climbing plant plentiful in Northern-India common in Bengal and in the Deccan extending
to Travancore and Ceylon.
The roots yield by simple distillation with water a stereotype root decoction, which is supposed
to be volatile acid.
The root decoction contains, an essential oil of which about 80% consists of a crystalline
material 2-hydroxy-4-methoxv benzaldehyde.
The odour of the drug is due to Caumarin. Two Sterols were isolated: hemidosterol and
hemidesmol. The roots also contains resins, tannin and very small amount of glycoside.
Hemidesmus Indicus used for its healing properties, there are many different ways in which the plant is
prepared. Most of the preparations call for the roots of the plant to be dried and ground into a fine powder,
which is then either mixed with other medicinal herbs to make salves and balms, or the powder is steeped
in warm water and then ingested as a tea. Hemidesmus Indicus is effective as an anti-inflammatory.
R.N.Chopra. I.C.Chopra. K.L.Handa. L.D.Kapur 1958. Indigenous Drug of India. 187-189.Acharva. D:
Sancheti. G; Shrivastava, A; et al. 2006."Rare Herb of PatalkotrHemidesmus indicus.disabled-
world.com.": Arun, V; Liju. V; Reena, J; et al. 2007. Traditional Remedies of Kani Tribes of Kottoor
Reserve Forest, Agasthyavanam, Thiruvananthapuram, Kerala. Indian Journal of Traditional
Knowledge. Austin, A. 2008. A Review on Indian Sarsaparilla, Hemidesmus indicus. Journal of
Biological Sciences.
Guduchi ( Tinospora cordifolia) is widely used in veterinary folk medicine/ayurvedic system of medicine for its general tonic, anti-periodic, anti-spasmodic, anti-inflammatory, anti-arthritic, anti-allergic and anti-diabetic properties (Nadkarni KM, Nadkarni AK, editors. Indian Materia Medico, Vol 1. 3rd ed. Mumbai: M/S Popular Prakasan Pvt. Ltd; 1976; Zhao TF, Wang X, Rimando AM, Che C. Folkloric medicinal plants: Tinospora sagittata var. Cravaniana and
Mahonia bealeu Planta Med 1991;57:505.). Recently, Estrogen like antiosteoporotic effects in bone of rats were observed with extracts of Tinospora cordifolia (Kapur P. Jarry H, Wuttke W, Pereira BM Seidlova-Wuttke D. Evaluation of the antiosteoporotic potential of Tinospora cordifolia in female rats, Maturitas. 2008 Apr 20;59(4):329-38.).
Eranda ( Ricinus communis) has been freely used all over India since centuries. Internally, root extract of eranda exhibits excellent anti-inflammatory activity in acute and chronic inflammatory models in rats (Ilavarasan R, Mallika M, Venkataraman S, Anti-inflammatory and free radical scavenging activity of Ricinus communis root extract, J Ethnopharmacol. 2006 Feb 20;103(3):478-80). The methanol extract of Sajina (Moringa pterygosperma) was used to evaluate its analgesic, anti-inflammatory and local anesthetic activity in the present study. Analgesic activity was tested in mice using various doses orally. Acetic acid-induced writhing episodes were significantly and dose-dependently reduced. At the same dose, its anti-inflammatory activity was also tested. Carrageenin (a standard inflammatory agent)-induced paw edema in mice was significantly reduced after oral administration. Furthermore, its local anaesthetic activity was tested in frog and guinea pig models, and it was seen that in both animals, the plant (root bark) produces significant local anesthetic activity. (Caceres ,J Ethnopharmacol,1992,36,233; Chem Abstr,1993,119,529. Preclinical and clinical investigations of Moringa pterygosperma for the reduction of pain, stiffness, improved function and tolerability in older patients of Musculoskeletal disorder (MSP) reported safe and effective use without any side effects during the trial (Singh BB, Mishra LC, Vinjamury SP, Aquilina N, Singh VJ, Shepard N:: Punarnava (Boerhaevia diffusa) have been widely used for the treatment of dyspepsia, jaundice, enlargement of spleen, abdominal pain and to treat liver disorders (Chandan, B.K., Sharma, A.K., and Anand, K.K. 1991. Boerhaevia diffusa: A study of its hepatoprotective activity. Journal of Ethnopharmacoloav 31(3):299-307. Kirtikar, K.R. and Basu, B.D. 1956. Indian Medicinal Plants. Vol. III. 2nd Edition. Lalit Mohan Basu. Allahabad. Uttar Pradesh. India. pp. 2045-2048, Rawat, A.K.S., Mehrotra, S., Tripathi, S.K., and Shama, U. 1997 :. Hepatoprotective activity in Punarnava - a popular Indian ethnomedicine. "Journal of Ethnopharmacology" 56(1):61-68.). In addition, its diuretic (Gaitonde, B.B., Kulkarni, H.J., and Nabar, S.D. 1974. Diuretic activity of punarnava (Boerhaevia diffusa). Bulletins of the Haffkine Institute (Bombay. India) 2:24.). as anti-inflammatory (Bhalla, T.N., Gupta, M.B., Sheth, P.K., and Bhargava, K.P. 1968. Antiinflammatory activity of Boerhaavia diffusa. Indian Journal of
Physiology and Pharmacology 12:37.), and antifibrinolytic (Jain, G.K. and Khanna. N.M. 1989. Punarnavoside: A new antifibrinolvtic agent from Boerhaavia diffusa Linn. Indian Journal of Chemistry 28(B): 163-166.).
SUMMARY OF THE INVENTION
The present invention provides an herbal tablet: "OSTRANIL PLUS" for the treatment of musculoskeletal disorder (MSD). The herbal composition comprises a therapeutically effective combination of plant parts or plant products of Hemidesmus indicus, Ricinus communis, Tinospora cordifolia, Boerhavia diffusa, Moringa pterigosperma and optionally along with pharmaceuticallv acceptable additives. The invention further comprises methods of making the herbal composition, into a tablet dosage form for the treatment of arthritis, musculoskeletal disorder etc.
A novel poly-herbal tablet composition comprising guduchi
i) Guduchi {Tinospora cardifolia)
ii) Eranda(Ricinus comminus)
iii) sajina (Moringa pterygospermd)
iv) Antamul (Hemidesmus indicus)
v) Punarnava (Boerhaevi diffusa)
Wherein Guduchi (Tinospora cardifolia) is in the range of 13.50% to 17.50%w/w Eranda (Ricinus comminus) in the range ofl6.50% to 20.50%w/w, sajina (Moringa pterygospermd) in the range of 9.50% to 13.50%w/w, Antamul (Hemidesmus indicus) in the range of 16.50%to 20.50%w/w Punarnava (Boerhaevi diffusa) inthe range of 5.50% to9.50%w/w,
Punamava(Boerhaevi diffusa),colloidal silicon I. P is in the range of0.06 to0.5% w/w the above composition used in the form of dry powder and extracts as actives.
The method of preparation of tablet of claim 1, comprising:
(i) dry mixing of different kinds (dry powder and extracts) of the herbs as actives with Different excipients,
(ii) Blending of dry mix with other adjuvant of the tablet composition,
(iii) The blend was processd for granulation and then pored into hoper of tablet machine for tablet punch. Then the punched tablets were coated for final blister packaging.
A BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWING
The accompanying Flow Sheet Drawing explains, the Steps of Invention, wherein the name
and the quantity of each components required in Kilograms, to produce I Million Numbers
of OSTRANIL PLUS TABLETS, are also, furnished:-PREPRATORY STAGE FOR INVENTION: AS PER FLOW SHEET. Initially after sourcing of the herbs (which, after Sun Drying and thereafter removal of balance 5-10 % of moisture content by Vacuum Evaporation /Drying System), are subjected to Size Reduction by Double Involute /Spiral Mill (having R.H.S. & L.H.S. involutes or spirals) to crush the fibrous characteristics of the herbs & then are be subjected to Fine Shredding Mills & forfurther reduction in size, in the order of Micron Size(s) by MICRONIZER Machines..
Step - 1. All the 14 Constituents are then passed through Tyler Mesh Screen or Sieve No. 60, having an opening of 0.246 mm or 246 microns.
Step — 2. Items No 1 & 2 as shown in the Flow Sheet by arrows are charged into Double Cone Blender and are mixed for 5 Minutes.
Step -3. Items Nos 4 to 6 are charged into a Stainless Steel Vat Coupled with 2 Spirals for Batch Mixing.
Step - 4 The Powders from Step 2 & 3 are charged into a double coned Blender & are Mixed
for 5 Minutes comprising of spirals, as stated. Step - 5 Items. Numbered as 7 to 14, are mixed in S.S. Vat coupled with Twin spirals for
complete batch mixing.. Step - 6. From Steps 4 & 5 the powders are charged in Double Cone Blender & Mixed for 5
Minutes.
Step-7 The powders are then removed from above Step no: 6 Step - 8 In this step the powder from Step 7 is processed for granulation. Step - 9 The Granules from Step 8, are coated with other adjuvant of tablet composition. Step 10 Coated Granules are compressed in a Rotary Tablet Making Press, to form Tablets. Step 11 Tablets are ready for Blister Packing.
DETAILED DESCRIPTION OF THE INVENTION
The main objective of the present invention is to provide a novel tablet dosage form of a herbal composition useful as an anti-inflammatory agent and provide relief in pain in cases of Musculoskeletal disorder (MSD). Another objective of the present invention is to provide a method of preparing an herbal composition useful as an anti-inflammatory agent and provide relief in pain in cases of MSD. Further, another objective of the present invention is to provide a method of treatment for inflammation and relief in pain in cases of musculoskeletal disorder using the tablet dosage form of the herbal composition of the present invention. The quantity of the individual ingredient incorporated is also based on the Ayurvedic medication system.
In the composition of tablet, Guduchi (Tinospora cardifolia) is used as an anti-inflammatory and
antiosteoporotic agent for musculoskeletal disorder.
In the composition of tablet, Eranda (Ricinus communis) is used as an anti-inflammatory agent in
acute and chronic inflammation associated with MSD.
In the composition of tablet, sajina (Moringa pterygosperma) is used for the reduction of pain
and stiffness, and to improve function and tolerability in MSD of knee.

In the composition of tablet, Annantamul (Hemidesmus indicus) is used to reduce inflammation and to improve joint health in MSP.
In the composition of tablet, Punarnava {Boerhaevi diffusa) is used as an anti-inflammatory and antifibrinolvtic agent for MSP.
As the quantities of the herbal active (s) are incorporated in different forms (dry powder and
extract), the composition and the method of manufacturing tablets comprise main part of this
invention.
Since, the two forms of each active herb are incorporated in the tablet the steps involved in the
manufacturing of these tablets are unique compared to manufacturing of other conventional
herbal tablets. Hence, these steps also comprise the part of this invention.
The present invention provides a poly-herbal tablet dosage form for relieving the distress in
musculoskeletal disorder and the manufacturing method comprises of the following steps
(See flow chart)
Weight Variation Test: Average wt. of the tablet is 616.1 mg.Tablets were subjected to weight
variation test as per USP. Quality control charts were plotted for ± 5% variation. As per the
QC charts, weight not more than one tablet was outside the limit of ± 5% and weight of none of
the tablets were outside double the percentage between (-5% to +5% fallowed. However, the
average weights of all the tablets were within ± 5%.
Disintegration test: the Tablets were subjected to disintegration time test as per USP. The
average disintegration time was 10.0 minutes. All the tablets were compliant with respect to
disintegration time test Average hardness of the tablet: 3.0 kg, Friability: less than 1%.
The results of the above mentioned quality control test indicate that the method used in the
analysis of the tablets was suitable and reproducible.
The invention can be appreciated from the following examples, which are intended as further
illustration, but not as a limitation on the scope of the invention.
Example 1: This example describes the manufacturing of poly-herbal tablets
The composition poly-herbal tablet (Wt of each tablet 616.1 mg) is given below (Table 1) Table 1:

(Table Removed)
Example2: Weight Variation Test
10 tablets were collected at an interval of 15 minutes for a period of 120 minutes. At each time interval, each tablet was weighed using an electronic balance (Precisa XB 600M-C). The tablet was unlocked and the content of the tablet was removed completely. The average content of the tablets at each time interval was determined. Finally gross average weight was calculated. A control chart of weight variation of the content of the tablets was prepared and the maximum and minimum weight spread was determined. The average weight of the content of the tablets was found within the Pharmacopoeial limit of+ 5% (variation limit.) Example3: Disintegration Test
Disintegration time test was carried out in USP disintegration test apparatus model ED-2L. Two tablets, of each time interval, were placed in baskets with guided discs. The baskets were immersed in purified water IP at 37°C and the baskets were allowed to move up and down. When the tablets disappeared from the baskets, the time was noted. Average disintegration time at each time interval was noted and the gross average disintegration time was determined. All the tablets are found to be within the pharmacopoeial limit.-16-

WE CLAIM:
1. A novel poly-herbal tablet composition comprising guduchi
i) Guduchi (Tinospora cardifolia)
ii) Eranda(Ricinus comminus)
iii) sajina (Moringa pterygospermd)
iv) Antamul (Hemidesmus indicus)
v) Punarnava (Boerhaevi diffusa)
wherein Guduchi (Tinospora cardifolia)is in the range of 13.50% to 17.50%w/w Eranda(Ricinus comminus) in the range ofl6.50% to 20.50%w/w, sajina (Moringa pterygospermd) in the range of 9.50% to 13.50%w/w, Antamul (Hemidesmus indicus) in the range of 16.50%to 20.50%w/w Punarnava (Boerhaevi diffusa) inthe range of 5.50% to9.50%w/w, Punarnava (Boerhaevi diffusa),co\loida\ silicon I. P is in the range of0.06 to0.5% w/w the above composition used in the form of dry powder and extracts as actives.
1. The composition as defined in claim 3 wherein Guduchi (Tinospora cardifolia) is at a
label 15.42% w/w.
2. The composition as defined in claim 3 wherein Eranda(Ricinus comminus) is at a label
18.26%w/w.
3. The composition as defined in claim 3 wherein sajina (Moringa pterygospermd) is at a
label 11.36% w/w.
4. The composition as defined in claim 3 wherein Guduchi {Tinospora cardifolia) is at a
label 15.42% w/w.
5. The composition as defined in claim 3 wherein Eranda(Ricinus comminus) is at a label
18.26%w/w.
6. The composition as defined in claim 3 wherein sajina {Moringa pterygosperma) is at a
label 11.36% w/w.
7 The composition as defined in claim 3 wherein Guduchi {Tinospora cardifolia) is at a label 15.42% w/w.
8. The composition as defined in claim 3 wherein Eranda(Ricinus comminus) is at a label
18.26%w/w.
9. The composition as defined in claim 3 wherein sajina {Moringa pterygosperma) is at a
label 11.36% w/w.
10. The composition as defined in claim 3 wherein Anantamul (Hemidesmus indicus) is at a label 18.26% w/w.
11. The composition as defined in claim 3 wherein Punarnava {Boerhaevi diffusa) is at a label 7.30% w/w.
12. The composition as defined in claim 3 wherein Colloidal Silicon Dioxide LP is at a label
0.12%-0.3%w/w.
13. The method of preparation of tablet of claim 1, comprising:
(i) dry mixing of different kinds (dry powder and extracts) of the herbs as actives with Different excipients,
(ii) Blending of dry mix with other adjuvant of the tablet composition,
(iii) The blend was processed for granulation and then pored into hoper of tablet machine for tablet punch. Then the punched tablets were coated for final blister packaging.
14. The tablet contains the bioenhancer for better bioavailability of the ingredients.
15. A novel poly-herbal tablet substantially as here in described with accompanying flow
charts and examples
16. A method of making poly-herbal tablets substantially as herein described with
accompanying flow charts.