Title of Invention	"ORAL ANTI-SPASMODIC ANTI-INFLAMMATORY COMPOSITION COMPRISING PITOFENONE, FENPERINIUM AND NSAID"
Abstract	An oral anti-spasmodic composition comprising diclofenac or its salts as herein described from 6.188 to 61.88 % w/w, Pitofenone hydrochloride from 0.39 to 12.38 % w/w, Fenpiverinium bromide from 0.006 to 1.24 % w/w along with other pharmaceutical excipients is provided.

Full Text

A NOVEL ANTI-SPASMODIC COMPOSITION. TECHNICAL FIELD The present invention describes a novel composition comprising a non-steroidal antiinflammatory drug and their salts and their chirally pure forms and two drugs pitofenone hydrochloride and fenpiverinium bromide in a pharmaceutically acceptable combination. BACKGROUND OF THE INVENTION Amongst the various non steroidal antiinflammatory drugs diclofenac particularly sodium diclofenac is widely used in the treatment of rheumatoid arthiritis, osteoarthirities and ankylosing spondylitis. This has been disclosed in the following references (references from US Pat 5202159) As such, Intestinal, ureteric and biliary colic are extremely common clinical conditions requiring prompt medical attention to relieve the symptoms and help the patient get back to his/her vocation to avoid/minimize economic loss and reduce the load on the medical institution. Non -surgical treatment can provide immediate relief to the patient while investigations are being carried out to determine the future course of management. Currently available treatment modalities include anticholinergics like, atropine and its derivatives, ambutonium, glycopyrronium , isoperopamide, pripenzolate, etc. Combination therapy with analgin, pitofenone and fenpiverinium are also used. In addition, drugs such as meberverine valethamate bromide, clidinium are also used with. All drugs do not provide predictably uniform results in all patients. All the drugs used in these conditions do carry some side effects. Anticholinergics produce dry mouth, tachycardia in some patients, are contraindicated in glaucoma and prostatic hypertrophy and other antispasmodic agents may cause drowsiness as a side effect. Analgin is implicated in causing bone marrow depression. In the comprehensive review of a pharmacological properties of Diclofenac Sodium (Brogden et al, Drugs 20/24-48 (1980) it has been reported to have anti inflammatory activity, analgesic activity and anti pyretic activity. Conventionally it has been used in clinical condition for rheumatic disorders. Recently it has been reported to be of use in painful non-rheumatic syndromes for example biliary colic, (Grossi et al. current Therapeutic Research, volumes 40 No. 5 (1986)} and acute renal colic {Garcia Alonso F. et al, Evr. J. clin Pharmacol 40, 543-546 (1991)} However it has been reported that Diclofenac Sodium intramuscular is more effective than Narcotic analgesic like pethidine intramuscular in the management of acute renal colic and has fewer side effects. Based on the market survey among the various products available as antispasmodic one major product is composed of Analgin with two spasmolytic agents that is pitofenone hydrochloride and fenpiverenium bromide. No pharmacological composition has been reported in literature as well as no product is available where Diclofenac sodium is employed in combination with Spasmolytic agents. Our findings as disclosed in this patent application indicate that non-steroidal antiinflammatory drugs such as diclofenac sodium when combined with fenpiverenium bromide and pitofenone hydrochloride forms an excellent antispasmodic composition. The composition when given orally and intramuscularally is not only clinically effective but is superior to the existing therapeutic agents. It is superior in two ways one it has more effective action and second it has fewer side effects. Accordingly, it is an object of the present invention to provide a novel anti-spasmodic composition comprising diclofenac and like non-steroidal antiinflammatory drugs and their salts and pitofenone hydrochloride and fenpiverinium bromide. It is a further objective of the present invention to provide a process for the manufacture of a novel anti-spasmodic composition comprising sodium diclofenac and pitofenone hydrochloride and fenpiverinium bromide. It is a further objective of the invention to provide a novel injectable delivery system for the anti-spasmodic composition. It is a further objective of the invention to provide an anti-spasmodic composition which can be taken orally by way of a Pediatric suspension, capsule/tablet. SUMMARY OF THE INVENTION An anti-spasmodic composition comprising a non-steroidal antiinflammatory drug, its salts and its chirally pure forms and two drugs pitofenone hydrochloride and fenpiverinium bromide . The composition is capable of being used in the form of an injection or a tablet. DETAILED DESCRIPTION OF THE INVENTION The various non-stimulatory antiinflammatory drugs that can be used along with Pitofenone hydrochloride and Fenpiverenium bromide are selected from Aspirin, Diclofenac, Diflunisal, Etodolac, Flurbiprofen/Flurbiprofen Sodium, Ibuprofen, Indomethacin/Indomethacin Sodium, Ketoprofen, Mefnamic Acid, Naproxen/Naproxen Sodium, Paracetamol, Phenylbutazone, Piroxicam, Sulindac, Ketorolac, Nimesulide and the like. Several formulations can be made in the form of tablets or injections comprising the three ingredients Diclofenac and like non-steroidal antiinflammatory drugs and their salts, Pitofenone hydrochloride and fenpiverenium bromide. Besides the ingredients disclosed above the composition also comprises the usual excipients like starch, microcrystaline cellulose, DCP, purified talc, magnesium sterate etc described in the standard text. Tablets may be film coated, sugar coated or specially coated as described in the existing art. (Pharmaceutical Dosage forms : Tablets, vol 1-3, Eds., H.A Lieberman and L. Lachman Dekker New York.) As disclosed earlier the composition can be employed in the tablet form or in the injection form. Such composition can be administered orally or by intramuscular route they can also be administered in form of modified release, sustained release, controlled release, timed release formulations. They can also be administered by ocular, intranasal, obuccal, sublingual, transdermal, rectal, vaginal and others related administration routes. In the tablet form the concentration of the three ingredients are Diclofenac and like non-steroidal antiinflammatory drugs and their salts - From 6.188 to 61.88 % w/w Pitofenone hydrochloride - From 0.39 to 12.38 w/w Fenpiverenium bromide - From 0.006 to 1.24 % w/w The tablets may contain specialised ingredients to modify, sustain or control release of one or more ingredients resulting in modified, sustained or controlled release products. (Controlled Drug Delivery Fundamentals and Applications, second edition eds., J.R. Robinson and V.H. Lee. Marcel Dekker, New York.) In the injection form the concentration of the ingredients are Diclofenac and like non-steroidal antiinflammatory drugs and their salts - From 1.0 to 10 % w/v Pitofenone hydrochloride - From 0.05 to 2.0 % w/v Fenpiverinium bromide - From 0.001 to 0.2 % w/v The vehicle of the injectable preparation may consist of aqueous, non aqueous or specially formulated amphiphilic base containing suitable stabilizers, antioxidants buffers and other additives. The drug(s) may be dissolved or suspended. The invention will now be described with reference to the foregoing examples: Example 1 Preparation of Antispasmodic tablets Quantity Quantity for S.No Component Per tablet 1.0 Lac tablet 1. Diclofenac Sodium 50.0 mg 5.0 Kg 2. Pitofenone Hydrochloride 5.0 mg 0.5 Kg 3. Fenpiverenium bromide 0.1 mg 0.01 Kg 4. Microcrystalline Cellulose 23.9 mg 2.39 Kg 5. *Starch 66.0 mg 6.6 Kg 6. Purified Talc 2.5 mg 0.25 Kg 7. Magnesium Stearate 2.5 mg 0.15 Kg 8. Sodium Starch glycollate 1.5 mg 0.15 Kg 9. Sodium Lauryl sulphate 1.5 mg 0.15 Kg 10. Povidone 3.0 mg 0 . 3 Kg 11. Isopropyl alcohol 5.0 Itr. *Taken 10 % extra to compensate for loss on drying FILM COATING FORMULA Hydroxy Propyl Methyl Cellulose 8.0 mg 0.800 Kg PEG 400 0.8 mg 0.08 Kg Isopropyl Alcohol - 7.5 Itr Methylene Chloride - 15.0 Itr Purified Talc 1.4 mg 0.14 Kg Titanium Dioxide 1.4 mg 0.14 Kg Step 1. All the ingredients were weighed and sieved through a sieve of mesh size 60 (linear inch). Step 2. Diclofenac Sodium (5.0 Kg) was mixed with Microcrystalline cellulose (2.39) and starch (6.6Kg) Step 3. Pitofenone hydrochloride (0.5 Kg) and Fenpiverenium bromide (0.01 Kg) are geometrically mixed and then added to the bulk of step 2. Step 4. A solution of polyvinyl pyrrolidone (0.3Kg) in Isopropyl Alcohol (5.0 Itr) was prepared. Step 5. Granulated the bulk of step 3 with the binder solution (bulk of step 4) Step 6 The wet mass was passed through sieve no 18 to obtain granules which were dried at a temperature Of 45-50°C and dry sieved through sieve no 18. Step 7. Magnesium stearate (0.25 Kg), purified talc (0.25 Kg) Sodium Lauryl sulphate (0.15 Kg) and Sodium starch glycloate (0.15 Kg) was passed through sieve of mesh size 60. Step 8. Mixed the bulk of step 7 with that of step 6. Step9. The bulk of step 8 is compressed into tablets in a tablet compression machine at on average weight of 150.0 mg. Step 10. A film coating solution is passed through colloid mill and the core tablets is coated with it. Example 2 Preparation of anti spasmodic injection S.No Component Per ml for 1.0 lac Ampoules 1. Diclofenac Sodium 25.0 mg 7.5 Kg 2. Pitofenone Hydrochloride 2.0 mg 0.6 Kg 3. Fenpiverenium bromide 0.02 mg 0.006 Kg 4. Benzyl Alcohol 5.12 mg 1.536 Kg 5. Propylene glycol 0.4 ml 12.o Itr 6. Sodium sulphite (anhydrous)1.0 mg 0.3 Kg 7. *Hydrochloric acid 0.002 ml 0.6 Itr (concentrated) 8. D-Mannitol 5.0 mg 1.5 Kg 10. Disodium Edetate 0.67 mg 0.201 Kg 11. Water for Injection qs to 1.0 ml qs to 300 Itr * if required NB 1.0 lac Ampoules = 300 Itr. Step 1. Benzyl alcohol (1.8 Kg) is distilled at 204 to 208° C. The first and last portion is rejected and stored under nitrogen. Step 2. Diclofenac sodium (7.5 Kg)is dissolved in water for injection (75.0 Itr) and warmed, if required. Step 3 .Benzyl Alcohol (1.536 Kg),is dissolved in propylene glycol (120.0 Itr). Step 4. Bulk of step 3 is added to bulk of step 2 and mixed. Step 5. Pitofenone Hcl (0.6 kg) is dissolved in WFI (3.0 Itr) and added to bulk of step 4 and mixed. Step 6. Fenpiverenium bromide (0.06 Kg) is dissolved in WFI, (1.0 Itr), and added to the bulk of step 5 and mixed. Step 7. D-Mannitol (1.5 Kg), Sodium sulphite (0.3 Kg) and Disodium Edetate (0.201 Kg) is dissolved in WFI (10.0 Itr), added to the bulk of step 6 and mixed. Step 8. The pH of the bulk of step 7 is adjusted to between 8.2 and 8.8 if required by addition of hydrochloric acid. Step 9. The volume is made to 300.0 Itr.by the addition of EFI. Step 10. The bulk is sterilised by filtration using 2 u prefliter and 0.22 u filter under nitrogen. Step 11. The sterilised liquid is filled in amber coloured ampoules (3.0 ml per ampoule), flushed with nitrogen and sealed using ampoule filling and sealing machine. NOTE- Step 10 and 11 is carried out in aseptic area. CLINICAL TRIALS The following patients were included: * Patients in the age group of 16-60 years * Non-pregnant females were also included * Patients with biliary, intestinal and ureteric colic * Patients with any of the above conditions who could not be administered antispasmodic drugs belonging to the anticholinergic group (patients with glaucomam prostatic hypertrophy ) were also included. The following patients were excluded: * Patients with peptic ulcer disease * Patients requiring immediate surgery for their underlying condition were also excluded from the study. SAMPLE SIZE: Fifty patients. STUDY PROCEDURE: The study was open labeled. Patients attending the surgical OPD with complaint of moderate to severe abdominal pain and diagnosed to have one of the conditions listed in the inclusion criteria were enrolled. According to the study protocol, patients could be hospitalized for the acute condition for observation, and parenteral drug to relieve the acute pain was permitted. If on observation for a few hours, the patient is relieved of the pain but requires oral medication for continued relief of pain after discharge from the ward, the patient was put on test medication if the patient qualified the inclusion criteria. ADMINISTRATION OP THE TEST DRUG. The test drug was administered orally, The dose was one tablet three times daily for a maximum period of five days. Patients administered the test drug were kept in the emergency ward for observation till such time the patient was relieved of the symptoms. The protocol permitted patients to receive parenteral antispasmodic in cases of severe and disabling colic. Such patients were discharged on the oral test drug given in the dose of one tablet threice daily for a maximum period of five days. CONCOMITANT MEDICATION AND DIETARY ADVICE: Concomitant medication such as antibiotics, urinary antiseptics, medical therapy for gall stones, etc were continued during the protocol therapy. Similarly, any specific dietary restrictions/ advice were also continued. Patients were not permitted any concomitant antispasmodic therapy during the trial. ESCAPE MEDICATION AND TERMINATION OF PROTOCOL THERAPY: Patients not responding to the test medication within a period of two (2) hours were administered parenteral analgesic. Such patients were deemed treated and not replaced by fresh patients. All patients on enrollment were subjected to history, clinical examination and history of past drug therapy which included: 1. Duration of illness 2. Severity of pain 3. Frequency of antispasmodic drug intake 4. Duration of antispasmodic drug use 5. Relief with existing therapy; excellent, good, fair poor 6. Need to take parenteral antispasmodic while on existing oral therapy 7. Side effects with current therapy EVALUATION PARAMETERS: The following parameters were used to determine the efficacy and safety of the test medication. 1. Did the patient receive parenteral antispasmodic prior to oral therapy with the test drug. 2. Severity of pain after the first dose 3. Speed of relief 4. Did the patient need parenteral drug for pain relief after administration of the first dose of the test drug. 5. Severity of pain at home after subsequent doses 6. Duration of intake of test drug 7. Patient's evaluation of the test drug 8. Investigator's evaluation of the test drug FINAL EVALUATION: EXCELLENT: Acute pain relieved in less than half an hour. Parental drug for pain relief not needed. Drug well tolerated with out any side effects GOOD rAcute pain relieved in one to two hours without any need for parenteral drug for pain relief. Drug well tolerated without any side effects. POOR : Drug not effective in relieving pain. Parental drug required to control symptoms. RESULTS Total number of patients enrolled : 50 Number of patients completing the study : 50 DIAGNOSTIC BREAKUP OF PATIENTS ENROLLED DIAGNOSIS NUMBER MALE FEMALE Intestinal colic 23 11 12 12 12 0 23 Ureteric colic Biliary colic Total Males Females 19 8 50 MEAN AGE OF PATIENTS- YEARS 3.5 40.6 DURATION OF ILLNESS- years 7 8 27 DIAGNOSIS Intestinal colic (n=23) Ureteric colic (n=19) Biliary colic (n=8) MALES 5.8 (11) 6.8 (12) (0) FEMALES 6.9 (12) 7.2 (7) 7.3 (8) DURATION OF ANTISPASMODIC DRUG USE-Years DIAGNOSIS Intestinal colic Ureteric colic Biliary colic MALES 5.1 6.0 FEMALES 6.4 7.0 6.8 FREQUENCY OF ANTISPASMODIC DRUG INTAKE Tablets/week DIAGNOSIS MALES FEMALES Intestinal colic 6 10 Ureteric colic 7 12* Biliary colic 15 *p From the above tables of demographic details, there is no statistically significant difference between the two sexes with relation to age, diagnosis and duration of illness. However, there is a statistically significant dirrerence in the mean number of tablets per week consumed for the relief of ureteric colic for female patients in comparison to males (p,0.05). Since there were no male patients with biliary colic, it is not possible to determine the difference between the two sexes. Past history of parenteral antispasmodic drug intake Almost all patients needed parenteral antispasmodic drugs for symptomatic relief while on oral antispasmodic drugs. Although all patients were not able to exactly remember, the frequency of parenteral antispasmodic drug therapy varied from once every one month to two to four times every month. Most of the patients of both sexes reported uniformly good response with existing antispasmodic drug therapy. Five patients of intestinal colic, three of ureteric colic and two of biliary colic reported uncomfortable side effects such as, dry mouth and pa/petitions with anticholinergic drugs. Need for additional parenteral antispasmodic drug in the present study: No patient required parenteral antispasmodic in the present study. INTENSITY OF PAIN AFTER THE FIRST DOSE (As measured on visual analogue scale 0-100 mm) DIAGNOSIS INTENSITY OF PAIN 30 minutes 1 hour 2 hours Intestinal colic 55 23* 12* Ureteric colic 64 22* 13* Biliary colic 70 25* 17* *P There was a statistically significant reduction in the intensity of pain in all groups of patients at the end of one hour of the first dose. This indicates that the onset of action of diclofenac + pitafenone and fenpiverinium starts within this time period. DURATION OF HOSPITALIZATION-HOURS DIAGNOSIS DURATION Intestinal colic 2.8 Ureteric colic 3.9 Biliary colic 4.3 INTENSITY OF PAIN AT THE TIME OF DISCHARGE DIAGNOSIS INTENSITY OF PAIN Intestinal colic 7.75** Ureteric colic 8.25** Biliary colic 9.12** **p There was statistically highly significant reduction of pain at the time of discharge as measured by the visual analogue scale. INTENSITY OF PAIN DAY 2-5 (As measured by visual analogue scale 0-100 mm) INTENSITY OF PAIN DAY 2-5 DIAGNOSIS DAY 2 DAY 3 DAY 4 DAY 5 Intestinal colic 1.2** 0 Ureteric colic 2.1** 0 Biliary colic 3.2** 1.3 **P All patients had paractically no pain from day 2 onwards as measured by the visual analogue scale. All patients had the last dose of the test drug at approximately 8 p.m on day 1. This indicates that the duration of action of the test antispasmodic is more than 8 hours. INTAKE OF TEST ANTISPASMODIC- DAY 1 TO DAY 5 NUMBER OF TABLETS PER DAY DIAGNOSIS DAY1 DAY 2 DAY 3 DAY 4 DAY 5 Intestinal colic 32 1 00 Ureteric colic 32 1 00 Biliary colic 322 1 0 All the patients irrespective of diagnosis took three tablets on day 1 and 2 tablets on day 2. However, on day 3 patients of intestinal and ureteric colic took 1 tablet and did not take any tablets on days 4 and 5 while patients of biliary colic continued to take 2 tablets on days 2 and 3 and one tablet on day 4. on day 5 patients of biliary colic did not need any medication. Patients were instructed to bring the container along with the unconsumed tablets to the clinic on day 5 to determine the number of tablets the patients actually consumed after discharge from the hospital. EVALUATION OF THE TEST DRUG BY THE PATIENT Worse than previous therapy NIL Same as previous therapy 24 Better than previous therapy 22 Markedly better than previous therapy 4 EVALUATION OP THE TEST DRUG BY THE INVESTIGATOR EXCELLENT (Relief of pain WE CLAIM; 1• An anti-spasmodic composition comprising a non-steroidal antiinflammatory drug, its salts and its chirally pure forms and two drugs pitofenone hydrochloride and fenpiverinium bromide. 2. A composition as claimed in any of the preceeding claims wherein the said non-steroidal antiinflammatory drug is selected from the group comprising Aspirin, Diclofenac, Diflunisal, Etodolac, Flurbiprofen/Flurbiprofen Sodium, Ibuprofen, Indomethacin/Indomethacin Sodium, Ketoprofen, Mefnamic Acid, Naproxen/Naproxen Sodium, Paracetamol, Phenylbutazone, Piroxicam, Sulindac, Ketorolac, Nimesulide and the like. 3. A composition as claimed in claim 1 or 2 wherein said non- steroidal antiinflammatory drug is diclofenac and its salts. 4. A composition as claimed in claim 3 wherein said said salts of diclofenac are sodium, ammonium, potassium and epolamine. 5. A composition as claimed in claim 3 or 4 wherein the non- steroidal antiinflammatory drug employed in the composition is diclofenac sodium. 6. A composition as claimed in any of the preceeding claims wherein the composition is in the form of a tablet. 7. A composition as claimed in claim 6 wherein the ingredients are present in the following proportions : Non-steroidal antiinflammatory drugs including Diclofenac and their salts - From 6.188 to 61.88 % w/w Pitofenone hydrochloride - From 0.39 to 12.38 w/w Fenpiverenium bromide - From 0.006 to 1.24 % w/w 8. A composition as claimed in claim 7 wherein the tablet form also comprises fillers, binders, glident, lubricant, dissolution enhancer, and stablizer and other conventional ingredients. 9. A composition as claimed in claim 8 wherein the solvent employed for the composition is isopropyl alcohol. 10. A composition as claimed in claim 9 wherein the composition also comprises specialised ingredients to modify, sustain or control release of one or more ingredients resulting in modified, sustained or controlled release products. 11. A composition as claimed in any of the preceeding claims 1 to 5 wherein the said composition is in the form of an injection. 12. A composition as claimed in claim 11 wherein the said composition has the ingredients in the following proportions: Non-steroidal antiinflammatory drugs including Diclofenac and their salts - From 1.0 to 10 % w/v Pitofenone hydrochloride - From 0.05 to 2.0 % w/v Fenpiverinium bromide - From 0.001 to 0.2 % w/v 13. A composition as claimed in claim 10 wherein the vehicle for the said composition in the injectable form consists of aqueous, non aqueous or specially formulated amphiphilic base containing suitable stabilizers, antioxidants buffers and other additives. 14. A composition as claimed in claim 11 wherein the composition in the injectable form comprises pain reducers, anti oxidant, Ph adjuster, stabilizer, chelating agent and other conventional ingredients. 15. A composition as claimed in claim 11 wherein the said pain reducers, anti oxidant , Ph adjuster, stabilizer, and chelating agent are benzyl alcohol, sodium sulphite, hydrochloric acid, D mannitol and disodium edetate respectively. 16. A composition as claimed in claim 14 wherein said solvent for the composition is propylene glycol. 17. A process for the manufacture of an anti spasmodic composition which comprises mixing together a non-steroidal antiinflammatory drug and two other drugs pitofenone hydrochloride and fenpiverenium bromide under conventional conditions. 18. A process as claimed in claim 17 wherein the composition is capable of being used as an injection. 19. A process as claimed in claim 18 which comprises distilling a pain reducer and dissolving it in a solvent, separately dissolving a non-stimulatory antiinflammatory drug in water, mixing the said pain reducer with the said non- stimulatory antiinflammatory drug to form a dissolved mixture,mixing Pitofenone hydrochloride with said dissolved mixture, adding thereto fenpiverinium bromide to form the desired injectable composition. 20. A process as claimed in claim 19 wherein a stabilizer, antioxidant and chelating agent is added to the mixture of the three drugs. 21. A process as claimed in claim 19 wherein said pitofenene hydrochloride, fenpiverinium bromide, stabilizer, antioxidant, and chelating agent are dissolved in water for injection. 22. A process as claimed in claim any of the preceeding claims 17 to 21 wherein the pH of the mixture is adjusted between 8.2 to 8.8 by the addition of hydrochloric acid. 23. A process as claimed in claim 19 wherein the pain reducer is benzyl alcohol. 24. A process as claimed in claim 19 wherein the solvent is propylene glycol. 25. A process as claimed in claim 21 wherein the antioxidant, stablizer and chelating agent are sodium sulphite, D-Mannitol and disodium edetate. 26. A process as claimed in claim any of the preceding claims 17 to 25 wherein said non-steroidal antiinflammatory drug is selected from the group comprising Aspirin, Diclofenac, Diflunisal, Etodolac, Flurbiprofen/Flurbiprofen Sodium, Ibuprofen, Indomethacin/Indomethacin Sodium, Ketoprofen, Mefnamic Acid, Naproxen/Naproxen Sodium, Paracetamol, Phenylbutazone, Piroxicam, Sulindac, Ketorolac, Nimesulide and the like. 27. A process as claimed in claim 25 wherein said non-steroidal antiinflammatory drug is diclofenac and its salts. 28. A process as claimed in claim 25 wherein said said salts of diclofenac are sodium, ammonium, potassium and epolamine. 29. A process as claimed in claim 28 wherein the non- steroidal antiinflammatory drug employed in the composition is diclofenac sodium. 30. A process as claimed in any of the claims 17 to 29 wherein the said composition has the ingredients in the following proportions: Non-steroidal antiinflammatory drugs including Diclofenac and their salts From 1.0 to 10 % w/v Pitofenone hydrochloride - From 0.05 to 2.0 % w/v Fenpiverinium bromide - From 0.001 to 0.2 % w/v 31. A process as claimed in claim 30 wherein the vehicle for the said composition in the injectable form consists of aqueous, non aqueous or specially formulated amphiphilic base containing suitable stabilizers, antioxidants buffers and other additives. 32. A process as claimed in claim 30 wherein the composition in the injectable form comprises pain reducers, solvent, anti oxidant, Ph adjuster, stabilizer, chelating agent and other conventional ingredients. 33. A process as claimed in claim 17 wherein the composition is capable of being used in the form of a tablet. 34. A process as claimed in claim 33 which comprises mixing non steroidal anti-inflammatory drug with a filler and binder, adding to it a mixture of pitofenone hydrochloride and fenpiverenium bromide, preparing separately a mixture of polyvinyl pyrrolidone in a solvent, and mixing it to the said mixture of the three drugs, granulating the mixture, and adding thereto lubricant, glident, and dissolution enhancer and producing the tablets in a conventional manner. 35. A process as claimed in claim 34 wherein after the steps of granulation of the mixture the granules were dried at the temperature of 45 to 50° and dry sieved. 36. A process as claimed in claim 34 wherein the said filler and binder is microcrystalline cellulose and starch and said glident, lubricant and dissolution enhancer are purified talcum, magnesium stearate, sodium starch glycollate and sodium lauryl sulphate respectively. 37. A process as claimed in any oneof the claims 33 to 36 wherein the ingredients are present in the following proportions : Non-steroidal antiinflammatory drugs including - From 6.188 to 61.88 % w/w Diclofenac and their salts Pitofenone hydrochloride - From 0.39 to 12.38 w/w Fenpiverenium bromide - From 0.006 to 1.24 % w/w 38. A process as claimed in claim 37 wherein the tablet form also comprises fillers, binders, glident, lubricant, dissolution enhancer, and stablizer and other conventional ingredients. 39. A process as claimed in claim 37 wherein the solvent employed for the composition is isopropyl alcohol. 40. A process as claimed in claim 37 wherein the composition also comprises specialised ingredients to modify, sustain or control release of one or more ingredients resulting in modified, sustained or controllrd release products. 41. An anti-spasmodic composition substantially as herein described with reference to the foregoing examples. 42. A process for the production of an ant i-spasmodic composition composition substantially as herein described with reference to the foregoing examples. 43. A process for the production of an antispasmodic composition in the form of a tablet substantially as herein described with reference to the foregoing examples. 44. A process for the production of an antispasmodic composition in the form of an injection substantially as herein described with reference to the foregoing examples.

Documents:

791-del-1996-abstract.pdf

791-del-1996-claims.pdf

791-del-1996-correspondence-others.pdf

791-del-1996-correspondence-po.pdf

791-del-1996-description (complete).pdf

791-del-1996-form-1.pdf

791-del-1996-form-13.pdf

791-del-1996-form-19.pdf

791-del-1996-form-2.pdf

791-del-1996-form-29.pdf

791-del-1996-form-3.pdf

791-del-1996-form-4.pdf

791-del-1996-gpa.pdf

791-del-1996-petition-124.pdf