Dr. M.D. Nair

KOCHI

19.6.2010

Dr. M.D.Nair is a renowned pharmaceutical scientist. Dr.Nair has a Ph.D. Degree from the University of Illinois, USA. He was a Fulbright Scholar, a Fellow of the National Research Council of Ottawa, Canada, Alfred P. Sloan Research Foundation, New York and Research Associate at University of Illinois.

He joined the Pharmaceutical Research Group of CIBA Limited, Switzerland, and later of Ciba-Geigy Research Centre in Bombay. He has worked with several pharmaceutical companies across the world on New Drug Development, Patents, Documentation and Information Systems and Planning & Control of Production, Marketing and Clinical Trials. He is the holder of several patents on new therapeutic agents and has authored over 80 publications in various national and international journals.

His areas of specialty include Patents, Documentation and Information Management for the Pharmaceutical Industry, R&D Strategies and Management, Project Identification and Evaluation and Development of Biotechnology and Traditional Medicine based products.

In addition to various offices, he is also the Chairman of the trust which manages Indo-American Hospital at Vaikom.

• Introduction to Osteoarthritis (OA)

• Current Status of Treatment of OA & associated Medical Needs

• Collagen – The Ubiquitous Protein

• Collagen Peptide in Osteoarthritis treatment- Rationale

• Collagen Peptide – Evolution & Properties

• Pre-clinical & Clinical evidence of use in OA

• Primarily a disorder of hyaline cartilage and sub-chondral bone, though all tissues in and around involved joints are hypertrophic.

• Traditionally characterized in 2 broad groups, primary (idiopathic) and secondary (due to a causative factor or a disease).

• Mean age of onset is the 5th decade of life. Women are generally more affected.

• In one study it was established that 50% of > 65 age population have radiographic evidence of OA and around 10% have disabilities.

• Characterized by progressive disintegration of articular cartilage.

• Aetiology not understood, cannot be solely attributed to normal wear and tear.

OsteoarthritisLeading cause of pain and disability

Low awareness

Half of all chronic conditions in

persons aged over 65

9.6% of men and 18% of women ≥ 60

years have symptomatic OA

80% of those with OA have limitations in movements and

20% cannot perform their daily activities

• Obesity

• Joint Damage

• Ageing

• Gender

• Heredity

• Life Style & Habits

• Objectives :

– Reduce Pain, Increase joint mobility & Lessen further damage

– According to Mayo Clinic , U.S.A (2009)

There is no known cure for OA

Options

1. Pain killers: Acetaminophen, Aspirin , Piroxicam, Proxyvone & others used for R.A., NSAIDS

2. Cortisone injections

3. Hyaluronic acid injections ( Visco supplementation)

4. Lifestyle Modifications

5. Surgical Replacement

6. The needed chronic drug treatments can result in hepatic & nephro-toxic reactions and higher risks for CHD & gastric disorders. Wide spread use of Glucosamine (with or without Chondroitin Sulphate) is not supported by any scientific data (American J. Medicine- 2010)

• Collagen is the most abundant protein in mammals constituting one third of body proteins.

• There are at least 29 types of collagen so far identified, however Types I to IV constitute 90%.

• It is an incredible protein with three helical strands curled into one Super helix.

• Its triple helix structure was unraveled by Indian Scientists, G.N.Ramachandran & G. Kartha , hailed as one of the landmark biology discoveries of the Century matching the discovery of the double helix structure of DNA.

• India therefore has an emotional attachment to Collagen

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Collagen Sculpture- 11’ 3’’ tall in OrangeSculpture Park, SF, U.S.A. - Juhan Voss Andrews (2008)

‘Artists & Scientists seek world’s wonders, visible & invisible’

Collagen Peptide

Derived from Natural

Collagen Protein

Unique aminoacid

composition

GRAS

Supplies the amino acids for collagen synthesis in

body

Supplement for healthy cartilage, skin, bone

Sources –Fish, Bovine,

Pork

• A hydrolyzed form of Collagen Protein

• Water soluble without gelling property

• Amino acid Composition of collagen peptide is same as collagen in human body.

• Contains all essential amino acids except Tryptophan.

• Glycine, Proline and Hydroxyproline are present at 10-20 folds the concentration found in other proteins .

• Sulphur containing amino acids are low.

Stimulatory effect of collagen peptides on cartilage may be beneficial to make up of loss of cartilage in patients with Osteoarthritis

Absorbed peptides is believed to stimulates the anabolic effect on chondrocytes and initiates the repair process in cartilage

These peptides are absorbed into the blood stream

Protein gets decomposed to tri, di-peptides, amino acids within the stomach and small intestine.

• Absorption (using radio-labeled Collagen Peptide)

• Gets absorbed as di and tri peptides as well as, amino acids into the blood. Pro & Hyp are the major constituents.

• Accumulation of absorbed Collagen Peptide in the Joint Cartilage

• Understanding Biosynthetic pathways

• Effect On Articular cartilage - in-vitro & in-vivo (mouse model)

• Effect on Bone metabolism (rat model)

• Collagen Peptide stimulates the chondrocytes (cartilage cells) to initiate the anabolic phase of cartilage metabolism

• 18 Studies have so far been conducted

• comprising open, randomised, comparative & double blind protocols and results published.

• Several new trials are under way in many centers including in India sponsored by NITTA GELATIN LTD.

• The Primary objectives are , establishing safety and efficacy in

• Improvement of musculature

• Pain reduction

• Improvement in joint mobility

• Understanding Pharmacokinetic behavior

A recent study (using MRI) has shown evidence of cartilage regeneration. Further, trials established safety and alleviation of pain and improvements in joint movements

CLINICAL STUDIES

Patients with Osteoarthritis

Patients with Osteoporosis

Our joints undergo significant changes as we age, exercise and engage ineveryday activities. These changes can lead to chronic joint symptoms suchas discomfort, aching, stiffness, loss of flexibility and swelling in and around ajoint. So Collagen Peptide can be effective joint health supplement for thefollowing categories:

• The elderly• Obese people• Those involved in heavy manual work in their professions, sports, athletes• Patients with existing orthopedic conditions (including secondary

osteoarthritis) and false positioning of joints

Studies recommend daily 10gm of collagen peptide

It can be taken after dissolving in water, milk or any other beverages.

Improved flexibility and reduced stiffness and pain can be experienced within 2 to 3 months.

You should continue taking Collagen Peptide even after your pain disappear and flexibility returns, as symptoms will likely return if you discontinue therapy.