Express Pharma

Safeguarding the golden years

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Geriatric care and health management raises unique social, economic, and clinical challenges in India. From a pharma perspective, tackling their medication needs for complex health issues require special attention to protect their sunset years

Japan, the country with the highest number of old people, is also home to 117-year-old Nabi Tajima of Japan, now the oldest living person in the world whose age has been documented. He took over this slot from Violet Brown, another 117-year-old from Japan who died recently, on September 15, 2017. Yet, we have a contender from India as well. Almost a year back, Swami Sivananda from Varanasi claimed to be 120 years old and was in the process of applying for the Guinness World Record. Thus, lifespans in India too have increased significantly and thereby so has the number of older people in the country.

According to United Nations estimates, India has the largest youth population, but a report released by the Ministry of Statistics also reveals that the number of citizens over the age of 60 jumped 35.5 per cent — from 7.6 crores in 2001 to 10.3 crores in 2011.

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Utkarsh Palnitkar

The growing number of senior citizens in India have also created the need for healthcare methods which are suited for this population. Speaking in his personal capacity, As Utkarsh Palnitkar, Partner and Head, Infrastructure, Government and Healthcare, Life Sciences KPMG India points out, “India’s population is expected to grow from 1.32 billion in 2016 to 1.51 billion by 2030, an increase of 14 per cent. This is likely to, in turn, lead to a growing elderly population (aged 60 years above) which is projected to rise from 121 million in 2016 to 190 million by 2030, an increase of 56.2 per cent. This demographic shift will serve as a key driver for the demand of medicines in the country.”

Special attention for senior citizens

This necessitates the need for specially designed medication and treatment protocols to suit the needs of this population. There are several factors that need to be considered during formulation of medicines, drug delivery and treatment of the geriatric population. Palnitkar informs, “The prevalence of chronic disease in the geriatric patient population such as asthma and heart disease are more prevalent amongst Indian men, whereas ailments like arthritis, hypertension, cataract and diabetes are more prevalent amongst women. India’s epidemiological profile would, thus, become increasingly favourable for pharma companies as the burden imposed by chronic diseases grows.”

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Nishant Vaidya

Nishant Vaidya, Senior Product Manager, Bliss GVS Pharma also states, “The major concern for the elderly population are, loco motor disabilities, irritable bowel syndrome, heart diseases, skin disorders and mental disorders due to ageing brain.”

So, how do we handle the special and specific needs of this special population?

Depicting the Indian scenario, Palnitkar informs, “In India, elderly patients have a traditional mind-set and prefer conventional formulations such as oral and injectable. Doctors also find it challenging to explain the administration of suppositories and pessaries to elderly patients. Hence, promoting these dosage forms would be an ambitious task for pharma companies.”

However, Nishant Vaidya highlights the challenges and shortcomings in the traditional and conventional dosage and delivery methods and states, significance of identifying disease profiles and states, “In elderly population, pharmacokinetics are strongly influenced by co-morbidity, polypharmacy or impaired organ functions. Though oral formulation is widely accepted in the Indian market, these dosage formulations come with their own set of problems when used in elderly population.”

Are suppositories the answer?

Pharma companies like Sun Pharma, Cipla, Zydus Cadila, Abbott Laboratories, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb Company, Eli Lilly and Company, GlaxoSmithKline, Merck & Company, Novartis, Pfizer,  and Sanofi are some of the major players operating in the global geriatric medicines market for older group of population, however, there is still a void when it comes to providing specific treatment options suitable for geriatrics. For older population, pharma companies need to offer solution which has minimal side effects and effective treatments procedures.

Nishant Vaidya opines that suppositories could be the solution. He informs that globally, the suppository route represents a promising administration route for a wide range of therapeutic categories such as anti-malarial, laxative, contraceptive, anti-haemorrhoidal, anti-spasmodic, and anti-fungal. Globally, these forms are well accepted and assumed to be a possible treatment solution for the geriatrics in the near future.

Suppositories and pessaries provide several advantages such as avoidance of gastrointestinal irritation, provision of local effect on rectal mucosa, avoidance of first pass metabolism, reducing the chances of nausea, and vomiting and free from issue of taste.

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Anwar Daud

However, not everyone holds these views. Anwar Daud, MD, ZIM Laboratories says, “Although suppositories are popular in Europe and North Africa and provide an acceptable solution to oral delivery parenteral delivery and further provide reduction of adverse effects, they have never been acceptable well in the Asian countries because of cultural perception issues. Also, there is some amount of inconvenience as a majority of the patients in the population under discussion, will find it difficult to self-administer and cannot be administered ‘on the go’ in public while carrying out routine activity but needs private enclosures like bathrooms to be available at the right time.”

Vinod Arora, Principal Advisor, IGMPI, is another person who doesn’t completely agree that suppositories is the answer. He says, “In the West, suppositories delivery format is well accepted but in India its acceptance is poor. Bliss has been manufacturing suppositories for the last 15 years or more and have tapped many Big Pharma companies. However, to the best of my knowledge not a single product has touched the 100 crore mark.”

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Vinod Arora

He further narrates, “I worked on anti-malarial FDC suppositories for paediatric and during this time I also visited Bliss’ suppositories manufacturing facility for contract manufacturing. Later the product was dropped as there was a change in the business plan. We also debated on developing other molecules in suppositories dosage form for geriatric/ paediatric but, the management decided was not to go ahead with this delivery format due to the following reasons:

  • Inserting suppositories is a messy affair and is not patient friendly Suppositories Base -Wax/ Polyethylene/ Polymer base melts at ~450C which creates a challenge for storage/ transportation
  • Market Intelligence – Value wise sales of suppositories were not in line with organisation expectation.

Thus, it seems that presently Indian pharma companies are not offering enough suppositories- and pessaries-based therapeutic solutions to patient due to several reasons, such as patients comfort in taking oral formulations, low awareness of safety and efficacy of suppositories, traditional mind-set of patients and doctors finding it difficult to explain the administration of suppositories to patients. If these social behaviours are going to continue in future too then Indian pharma manufacturer needs to look for some alternate treatment options.

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Beside social psychology, cost also plays an important role in this. Daud explains, “The Indian market is price sensitive and many companies do not have the technical capabilities to formulate such complex or differentiated products targeted towards special populations convenience and adherence. Companies which use branded prescription based marketing have traditionally dependent upon fixed dose combinations for differentiation and providing multiple drug ingestion convenience and affordability.”

So, what are the other solutions to ensure good quality and effective medication and treatment to our senior citizens?

A quest for alternate solutions

Palnitkar shares his views on the alternate treatment methods Indian pharma companies should look for and suggests, “Novel Drug Delivery Systems (NDDS) products such as sustained released tablets, controlled released tablets, transdermal patches, etc. provide several clinical advantages for the geriatric patient population such as increase in safety, efficacy, a controlled and predictable release; decrease in dosing frequency; minimisation of side effects; and increase in patient compliance.”

Daud gives his opinion and says, “The other medicinal dosage forms include multi-particulates in capsules, transdermal patches, orally dispersible tablets and granules, oral films (the last three requiring good taste-masking etc).”

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Dr Himadri Sen

Dr Himadri Sen, Chairman, STEERLife suggests, “Effervescent dosage in the form of tablets that rapidly becomes a fizzy solution in water is a well suited oral dosage forms for geriatric patients. Effervescent tablets takes away the pain of swallowing large tablets by providing a convenient alternative of sipping a flavoured drink.”

However, these solutions are not very commonly used today. On being quizzed why Indian pharma companies are not offering such solutions to the Indian population, he says, “Effervescent manufacturing has been very cumbersome and very difficult to manage. However, there is a new effervescent platform technology from STEERLife that is called the ‘eximious technology’, which offers the ease of continuous granulation process for effervescent manufacture. We expect effervescence to gain a lot more traction in the coming months.”

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SR Vaidya

Yet, the drugs and the delivery systems are only a part of the whole. Geriatric care needs to be looked at in a broader, comprehensive and holistic manner. Fortunately, recognising this fact, some pharma companies are exploring the combination of patient service while administering drugs. For example; a multinational company is offering complimentary counselling service to diabetic patients who are on its insulin based drug.

Adherence to protocols is an essential factor when it comes to treating chronic ailments. In senior citizens, the problem of full term continuance of treatment is even more pronounced and such measures help ensure better adherence to treatment and medication protocols.

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A brighter future

As we near the World Elderly Day, observed on October 1 each year, it is to be hoped to that the lifesciences industry would continue to make strides in geriatric care. Afterall as SR Vaidya points out, “If we are able to prevent most of the apparent disorders in the geriatric population of our country, these very people will enable us to augment our society in terms of passing their valuable experiences in various fields.”

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