RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA
4th ‘T’ Block, Jayanagar, BANGALORE- 560 041
ANNEXURE-II
PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION
1 / Name of the Candidate andAddress / CHINMAYA KUMAR SENAPATI
S/o GOURANGA CHANDRA SENAPATI
At - Musanga Post – Kolha
Ps – Tihidi Dist – Bhadrak
Orissa – 756130
2 / Name of the Institution / AL-AMEEN COLLEGE OF PHARMACY
HOSUR ROAD,
BANGALORE - 560027
3 / Course of Study and
Subject / M. Pharma
(Pharmaceutical Marketing And Management)
4 / Date of Admission / 09/06/2008
5 / Title of the topic:
“To Study the Oxicams’ Market and Formulate a Launch Strategy for a Selected Oxicam”
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/ Brief resume of the intended work:
6.1 Need For The Study :
The Indian domestic pharmaceutical market posted a healthy growth of over 14% in September 2008 with a market value of Rs.33, 605 crores. According to June ‘07’ MAT, pain/analgesics were the second highest growth drivers of this market among the therapy areas [1]. The category witnessed high growth in value of 20% in June ‘07’ MAT as compared to the 12% value growth recorded in June ‘06’ MAT. The boost to this value growth was due to the non-steroidal anti-rheumatics which dominated, growing from 9% in June ‘06’MAT to 24% in June ‘07’ MAT [2]. The key growth driver has been new product introductions with pharmaceutical R&D continuing to suffer from declining productivity level and stagnant returns on investments, effective, flexible and commercially successful new product launches have become more important than ever.
Over the years the non-steroidal anti-inflammatory drugs have been commanding the worldwide attention of industrialists, economists, stock market analysts, researchers and physicians alike. More than any other group of NSAIDs, it is the oxicams, with their structural diversity that have given impetus to research interest in the search for more effective and better tolerated agents. These are enolic acids that inhibit COX-1 and COX-2 and have anti-inflammatory, analgesic and anti-pyretic activity. They are similar in efficacy to aspirin, indomethacin or naproxen for the long term treatment of rheumatoid arthritis or osteoarthritis. There are four oxicam drugs in the Indian market today – Piroxicam, Tenoxicam, Meloxicam and Lornoxicam. Our project is aimed at studying the market for the oxicams and formulate a launch strategy for a proposed brand of the latest member of the group, Lornoxicam which was launched in the year 1997 in the world market [3].
6.2 Review Of Literature
Oxicams are a group of structurally closed related chemical substances with analgesic, anti-inflammatory and also with antipyretic activities. They have a weakly acidic character. Most of the oxicams are well absorbed after oral administration with a low dose. Mainly oxicams have a moderate inhibitory activity on the synthesis and release of prostaglandins. They act by inhibiting COX, a key enzyme in arachidonic acid metabolism. The COX enzyme catalyzes the initial steps in the conversion of arachidonic acid to various eicosanoids, including prostaglandins (PGs) and thromboxanes. A major factor limiting their use is GI toxicity, ranging from mild dyspepsia to peptic ulcer to perforation and bleeding. This results from NSAID-induced disruption of the protective activities of PGE2 and prostacyclin formed by COX in the gastric mucosa [4, 5].
Piroxicam[6, 7]
Uses: Piroxicam is used in musculoskeletal and joint disorders such as ankylosing spondylitis, osteoarthritis, rheumatoid arthritis including juvenile idiopathic arthritis, in soft tissue disorders, in acute gout, and in postoperative pain .
Pharmacokinetics: Piroxicam is well absorbed from the gastrointestinal tract; peak plasma concentrations are reached 3 to 5 hours after an oral dose. Piroxicam is also absorbed to some degree after topical application .It is 99% bound to plasma proteins. It has been detected in breast milk. Piroxicam has a long plasma elimination half life about 50 hours. Because of this steady state concentrations are not reached for 7 to 12 days. It is metabolized in the liver by hydroxylation and conjugation with glucuronic acid and excreted mainly in the urine with smaller amounts in the faeces.
Administration: In rheumatic disorders a usual initial dose of piroxicam by mouth is 20 mg daily as a single dose. Daily maintenance doses may vary between 10 and 30 mg given in single or divided doses; use of doses in excess of 20 mg daily for more than a few days is associated with an increased risk of gastrointestinal adverse effects. In acute musculoskeletal conditions an initial dose of 40 mg daily may be given for 2 days followed by 20 mg daily for a total of 1 to 2 weeks. Piroxicam is also used in acute gout, the usual dose being 40 mg daily for 5 to 7 days .In the treatment of postoperative pain after dental or minor surgery; the dose of piroxicam is 20 mg daily; higher doses of 40 mg daily for the first two days are recommended following
orthopaedic surgery.
Adverse effects: The commonest adverse effects of NSAIDs are generally gastrointestinal disturbances, such as gastrointestinal discomfort, nausea, and diarrhea; these are usually reversible but in some patients peptic ulceration and severe gastrointestinal bleeding may occur. CNS related adverse effects include headache, vertigo, dizziness, nervousness, tinnitus, depression, drowsiness, and insomnia. Hypersensitivity reactions may occur occasionally and include fever, angioedema, and rashes. Some NSAIDs have been associated with nephrotoxicity such as intestinal nephritis and nephritic syndrome [7]. Local irritation and occasionally bleeding may occur with piroxicam suppositories and there may be pain and occasionally tissue damage at the injection site on intramuscular use. It is associated with an intermediate risk of gastrointestinal effects.
Interactions: Interactions involving NSAIDs include enchancement of the effect of the oral anticoagulants and increased plasma concentration of lithium, methotrexate, and cardiac glycosides. The risk of nephrotoxicity may be increased if given with ACE inhibitor, ciclosporin, tacrolimus, or diuretics. There may also be an increased risk of hyperkalaemia with ACE inhibitors and potassium-sparing diuretics. The antihypertensive effects of some antihypertensives including ACE inhibitors, β-blockers, and diuretics may be reduced. Convulsions may occur due to an interaction with quinolones. NSAIDs may enhance the effects of phenytoin and sulfonylurea antidiabetics. Use of aspirin with piroxicam results in decreased plasma concentrations of piroxicam to about 80% of normal. The use of piroxicam with ritonavir may result in increased plasma concentration of piroxicams and an increased risk of toxicity.
Tenoxicam.[6]
Uses: Tenoxicam is used in the symptomatic management of musculoskeletal and joint disorders such as osteoarthritis and rheumatoid arthritis, and also in the short-term management of soft-tissue injury.
Pharmacokinetics: Tenoxicam is well absorbed after oral doses; peak plasma concentration occur within about two hours in fasting; this may be delayed to about six hour when tenoxicam is given with food, but the extent of absorption is not affected. Tenoxicam is over 98.5% protein bound and penetrates synovial fluid. The plasma half life is about 60 to 75 hours; with daily dosage, steady-state concentration is reached within 10 to 15 days. Tenoxicam is completely
metabolized to inactive metabolites which are excreted mainly in the urine; there is some bilary excretion of glucuoronide conjugates of the metabolites.
Adverse effects: The majority of adverse effect of tenoxicam relate to the gastrointestinal tract (11.4%), nervous system (2.8%), or skin (2.5%). Other adverse effects are as for NSAIDs in general.
Administration: Tenoxicam is given by mouth as a single daily dose of 20 mg. In acute musculoskeletal disorders treatment for up to 7 days is usually sufficient but in severe cases it may given for up to maximum of 14 days. Doses similar to those given mouth have been given intramuscular or intravenous injection for initial treatment for 1 to 2 days. Tenoxicam has also been given by rectal suppositories.
Interactions: As for the NSAIDs in general.
Meloxicam[6]
Uses: Meloxicam is reported to be a selective inhibitor of cyclo-oxygenase-2. It is used in the management of rheumatoid arthritis, for the short term symptomatic treartment of acute exacerbations of osteoarthritis, and for the symptomatic treatment of ankylosing spondylitis. It may also used in the treatment of juvenile idiopathic arthritis.
Pharmacokinetics: Meloxicam is well absorbed after an oral dose. It is 99% bound to plasma proteins. Meloxicam has a plasma elimination half-life of about 20 hours. It is extensively metabolized mainly by oxidation and excreted similar amounts in the urine and in the faeces; less than 3% of a dose is excreted unchanged. The volume of distribution is increased in renal failure.
Adverse effects: As for the NSAIDs in general.
Administration: In the treatment of rheumatoid arthritis and ankylosing spondilitis, meloxicam is given by mouth in a usual dose of 15 mg daily as a single dose. Those with an increased risk of adverse reactions should be started on 7.5 mg daily. A dose of 7.5 mg daily is recommended for long term treatment in the elderly. In the treatment of acute exacerbations of osteoarthritis the usual daily dose of meloxicam by mouth is 7.5 mg, increased if necessary to a maximum of 15 mg daily given as a single dose.
Interactions: As for NSAIDs in general. There may be an increased risk of bleeding if
meloxicam is taken with pentoxifylline.
Lornoxicam[6]
Use: Lornoxicam is used as musculoskeletal and joint disorders such as osteoarthritis and rheumatoid arthritis; it is also used in the treatment of other pain conditions including post operative pain. Lornoxicam is also used in moderate to severe acute pain associated with dysmenorrhoea and dental or orthopaedic surgery.
Pharmacokinetics: Lornoxicam is almost completely absorbed from the gastrointestinal tract after oral administration with peak concentrations reached in one to two hour. After intramuscular doses peak concentrations are reached in about 25 minutes. Lornoxicam is 99% bound to plasma proteins. Lornoxicam is metabolized to its inactive hydroxylated metabolite. About one third of a dose is excreted via urine as inactive metabolites. The mean elemination half life is 3 to 4 hours.
Adverse effects: As for NSAIDs in general. Lornoxicam should not be used in patients with severe renal impairment. Intramuscular or intravenous use of lornoxicam is also contraindicated in moderate to severe renal impairment, severe hepatic impairment, severe cardiac insufficiency, hypovolaemia, dehydration, confirmed or suspect cerebrovascular bleeding, haemorrhagic diathesis, and operations with a risk of haemorrhage or incomplete haemostasis.
Interaction: As for NSAIDs in general. Increased rate of plasma concentrations of lornoxicam have occurred when given with cimetidine.
Administration: It is given in doses of 8 to 16 mg daily by mouth for the treatment of pain. Doses above 8 mg should be given in divided doses. Similar doses may be given by intravenous or intramuscular injection, although in rare cases the maximum initial daily dose may be increased to 24 mg; treatment by injection should be limited to 2 days.
An overview of the marketed brands of oxicam[8]
S No. / Drug / Mfg. by / Brand name / Strength / Dosage / Pack size / Price per pack (Rs) / Unit price (Rs)
1 / Piroxicam / Wockhardt / Brexic DT Tab. / 20 mg / Tablet / 10s / 26.98 / 2.69
Brexic capsule / 10 mg / Capsule / 6s / 9.6 / 1.6
Brexic capsule / 20 mg / Capsule / 6s / 14.9 / 2.4
Pfizer / Dolonex cap. / 20 mg / Capsule / 10s / 31.45 / 3.14
Dolonex DT. Tab / 20 mg / Tablet / 10s / 37.34 / 3.73
Dolonex Inj. / 20mg/ml / Injection / 1ml×5 / 43.15 / 8.6
Dolonex Inj. / 40mg/ml / Injection / 2ml×5 / 75.13 / 15.08
Sun / Feldex cap / 20 mg / Capsule / 10s / 54 / 5.4
Felcam DT / 20 mg / Tablet / 10s / 32.3 / 3.23
Cipla / Pirox cap / 20 mg / Capsule / 10s / 32.25 / 3.22
Ipca / Movon-20DT Tab / 20 mg / Tablet / 10s / 31.5 / 3.15
Movon Capsule / 20 mg / Capsule / 10s / 24 / 2.4
2 / Lornoxicam / Hetero H C / Lornoxi Tab / 4mg and 8 mg / Tablet
3 / Tenoxicam / Ranbaxy / Tobitil tab / 20 mg / Tablet / 10s / 51.8 / 5.18
Zy. cadila / Novotil tab / 20mg / Tablet / 10s / 54.8 / 5.48
4 / Meloxicam / Unichem / M-cam / 15mg / Tablet / 10s / 21.5 / 2.15
Cipla / Melflam / 15 mg / Tablet / 10s / 17.75 / 1.77
Dr. Reddys / Rafree / 15 mg / Tablet / 10s / 22.5 / 2.25
Rafree / 7.5mg / Tablet / 10s / 15.3 / 1.53
6.3:Objectives Of The Study:-
The study is aimed at achieving the following objectives
1. To study the position of the oxicams in the pain killers’ market.
2. To assess the potential of the key drugs in the oxicam class.
3. To arrive at the individual products competing in the oxicam’s market.
4. To identify the drugs/products benefiting the most from physician’s prescription and
5. the factors key to each product’s success.
6. To arrive a SWOT analysis of the oxicams’ market based on the results of the primary market research.
7. 6) To formulate a launch strategy for a selected oxicam..
7 / Materials And Methods:
7.1 Sources Of Data:
The source for market research will be include:
a) Primary source: Primary data will be obtained from market research which will be carried by a self administered questionnaire method.
1) Doctors:
Inclusion criteria: Orthopaedicians, Dentists, Physicians and General practitioners. Exclusion criteria: Doctors of other specializations and doctors involved in other systems of medicine (other than allopathy) will be excluded from the survey.
2) Chemists:
Inclusion criteria: Registered pharmacists at wholesale outlets, retail outlets, including hospital pharmacists.
Exclusion criteria: Pharmacists who are not registered will not be included in the survey.
b) Secondary source:
1) Journals:
¾ New England Journal of Medicine
¾ British Medical Journal
2) Pharma pulse
3) Pharma biz
4) Textbook of Pharma marketing
5) CIMS
6) Internet
7.2 Method of collection of data:
1) Preliminary communication with doctors and chemists to get their consent to participate in the survey.
2) Personal interview with doctors and chemists.
3) Sampling technique: Convenience sampling.
4) Sample size: 200
a) Doctors: 100
b) Chemists: 100
5) Survey area: The survey will be carried out in Bangalore and New Delhi.
7.3 Does the study require any investigation or interventions to be conducted on patients or other humans or animals ?
Doctors and Chemists will be interviewed; hence prior permission of the interviewee will be sought.
7.4 Has ethical clearance been obtained from your institution?
Applied for ethical clearance.
8. List of References :
1. http://www.medindia.net/news/Indian-pharma-Market-posts-Robust-Growth-43384-1.htm
2. McCormark K. The Evolving NSAID: Focus on Lornoxicam. PainReviews;6:4.1999:262- 78
3. ORG-IMS.June 2007
4. Hardman JG, Limbird LE. Goodman & Gilman’s the Pharmacological basis of Therapeutics.
10th ed. McGraw Hill Publishers;2001:713-715
5. URL:http://www.ncbi.nlm.nih.gov/pubmed/18479177?ordinalpos=4&itool=enterzsys
tem2.PEntrez.Pubmed.Pubmed_resultsPanel.pubmed_DefaultReportPanel.Pubmed_RVDocSUM.[cited on 2008 Nov 02]
6. Extra Pharmacopoeia. Martindale; 35th ed. [1] London: Pharmaceutical Press: 66,68,102,112.
7. Extra Pharmacopoeia. Martindale; 35th ed. [1] London: Pharmaceutical Press: 82,83,84,85.
8. Current Index of Medical Specialties. Jan-April 2008:237,232,231.
9. / Signature of the Candidate: / (CHINMAYA KUMAR SENAPATI)
10. / Remarks of the Guide: / Recommended for approval
11. / Name and Designation of:
11.1. Institutional Guide: / Dr. ASHA A N
Professor,Dept. of Pharmaceutical
Marketing and Management
11.2. Signature:
11.3. Co-Guide
11.4. Signature:
11.5. Head of the Department: / Dr.V.Kusum Devi
Professor and Head of Dept. Pharmaceutical
Marketing and Management
11.6. Signature
12. / 12.1. Remarks of the Principal / Forwarded to the University
12.2. Signature
/
Prof. B. G. SHIVANANDA
PrincipalAl Ameen College of Pharmacy
Hosur Road, Bangalore – 560 027.
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