Polypill
A polypill or single pill combination (SPC) is a type of drug combination consisting of a single drug product in pill form (i.e., tablet or capsule) and thus combines multiple medications (that is, more than one active pharmaceutical ingredient). The prefix "poly" means "multiple", referring to the multiplicity of distinct drugs in a given "pill". In precise usage, a pill is a polypill if it contains at least 4 drugs (meaning that fixed-dose combinations of 2 or 3 drugs are not polypills). An occasional synonym is combopill. A polypill is commonly targets treatment or prevention of chronic conditions.[1]
Polypills may be aimed to be consumed by healthy people as a means of
In addition to the noted fixed-dose types of polypills, polypills can also be custom-made for specific patients through a process called
For treatment or management of disease
Polypills are a useful therapeutic tool for those afflicted with various diseases/conditions, by consolidating multiple medications into a single product and thereby simplifying medication administration for healthcare personnel as well as alleviating pill-burden for patients.
HIV, mental-health, transplant, and certain other patient groups are known for especially high pill-burdens (whether temporary or indefinite). Also, elderly patients in particular are likely to require several medications on a daily basis for managing multiple conditions, and they are also particularly susceptible to difficulties remembering or keeping track of their regimen.
Origin of multi-drug pill usage
Combinatorial drug products were proposed for treating diagnosed conditions long before they were proposed for preventive medicine, including "aspolol" (a combination of aspirin and atenolol) for those diagnosed with cardiovascular disease. Fixed-dose combination (FDC) products today are also common for treating other diseases, such as tuberculosis and HIV/AIDS.
Developments in polypill usage for disease therapy
Treating cardiovascular disease
One of the first recommended roles of a polypill was as a means of providing recommended medications to people with heart disease, stroke and other forms of cardiovascular disease. Most cardiovascular disease patients do not receive recommended medications long-term: the proportion of cardiovascular disease patients not receiving a statin, aspirin and blood pressure lowering medication long-term ranges from about 50% in high income countries to over 90% in low income countries.[4] In 2001, a World Health Organization and The Wellcome Trust meeting of experts to discuss interventions for non-communicable diseases noted “the use of a single pill could well encourage patients to adhere to treatment as well as seriously reduce the cost of the drugs”[5] A programme of research was outlined, including stability and bio-availability testing followed by assessment of short-term effects on blood pressure, cholesterol, platelet aggregation, safety and side effects. In 2002, the World Health Organization Annual Report outlined the substantial potential public health impact and cost-effectiveness of scaling up access to combination cardiovascular treatment[6] and an editorial in The Lancet noted that a four component combination pill would reduce cardiovascular risk by about 75% among people with vascular disease.[7]
Treating diabetes and metabolic syndrome
Polypills have been proposed for managing
Role of compounding pharmacy
As noted, not all polypills are mass-produced fixed-dose (FDC) drug products. Physicians in many countries have wide discretion to prescribe customized drug products containing unique drug-dosage combinations and/or formulations thereof specifically for individual patients, which can then be custom-produced in a
Technologies are under development to facilitate production of customized polypills, such as for example by the use of ink-jet printing mechanisms to precisely deposit selected drug substance(s) onto sheets which can then be inserted into capsules (enabling "individualized dosing and automated fabrication of medicines containing multiple drugs," in addition to custom single-drug products).[9][10][11] Similar technology can also be used to print tablets, more directly. Ink-jet or fluid-jet approaches require each drug substance to be dissolved in a liquid solvent, but they can be particularly conducive to custom formulation with various possible excipients (in addition to custom drug/dose selections).
For preventive medicine
Origin of preventive medicine applications
Developments of preventive medicine applications
Any physician could currently prescribe all the components of many proposed polypills separately for their patients, whether therapeutically or preventively. And since the ingredients of many possible polypills are off patent, it can be cheap to commercialize, although FDC products with novel combinations or formulations can sometimes themselves be patented. Of course, for any FDC product, the potential market for a given combination of drugs/dosages would need to be sufficiently large to justify the clinical trials and other expenses associated with mass-producing a new drug.
Producing countries
The polypill, drugs to lower blood pressure, is produced[12][13] in Iran by the support of Execution of Imam Khomeini's Order was designed 14 years ag and called "PolyIran". According to the study was conducted by doctors from Tehran University, the University of Birmingham in Britain and other institutions and published by The Lancet, it worked quite well in a new study, slashing the rate of heart attacks by more than half among those who regularly took the pills. The pill in the study, which involved the participation of 6,800 rural villagers aged 50 to 75 in Iran, contained a cholesterol-lowering statin, two blood-pressure drugs and a low-dose aspirin.[14][15]
Certain "cardiovascular polypills" are currently available in India and have been extensively studied there (see Polycap and PolyIran, for examples). Also, cardiologists in Spain are developing a polypill for secondary cardiovascular prevention.[16]
Preventive use rationale: Treatment of population risk
Some preventive-use advocates propose that everyone over a given age (e.g., 55) should take such medications for preventive health, irrespective of individual risk factor levels. The idea is that most people in western countries are at high overall risk, thus lowering risk factor levels will provide broad benefit. This approach emphasizes the perspective that risk factors are continuous, and rigid dichotomies such as "hypertension" and "no hypertension" may be over-simplified and can be viewed instead as continuums of inter-connected factors.[17]
In this paradigm, doctors would in effect be treating population risk rather than individual risk factor thresholds as is current mainstream practice. So, if everyone were given a relevant kind of polypill, the average blood pressure and cholesterol levels in the population would fall, thus reducing overall population risk. Perhaps ironically, this is in a sense going in the opposite direction from
References
- ^ "WHO | Polypill holds promise for people with chronic disease". Archived from the original on November 1, 2013.
- ^ "Polypill".
- ^ PMID 12829553.
- PMID 21872920.
- ^ World Health Organization(2002) Secondary prevention of non-communicable disease in low and middleincome countries through community-based and health service interventions. World Health Organization - Wellcome Trust meeting report 1–3 August 2001, Geneva. http://www.who.int/cardiovascular_diseases/media/en/615.pdf
- ^ World Health Organization(2002) The World Health Report 2002. Reducing risks, promoting healthy life.;WHO, editor. Geneva: WHO. [1]
- S2CID 33042777.
- PMID 16868284.
- PMID 21360709.
- .
- PMID 22527973.
- ^ "بازتاب دستاورد جدید ستاد اجرایی فرمان امام در تولید دارویی برای سکته قلبی و مغزی". Isna. Retrieved 23 August 2019.
- ^ "تولید داروی پلی پیل و کاهش 50درصدی سکته قلبی و مغزی". فارس.
- ^ Gallagher, James (2019-08-23). "Four-in-one pill prevents third of heart problems". BBC News. Retrieved 23 August 2019.
- ^ McNeil Jr., Donald G. (2019-08-22). "This Daily Pill Cut Heart Attacks by Half. Why Isn't Everyone Getting It?". The New York Times. Retrieved 22 August 2019.
- S2CID 205339553.
- PMID 12089098.
Selected publications
- Fuster V, Sanz G (April 2007). "A polypill for secondary prevention: time to move from intellectual debate to action". Nat Clin Pract Cardiovasc Med. 4 (4): 173. PMID 17380163.
- Wald NJ, Law MR (June 2003). "A strategy to reduce cardiovascular disease by more than 80%". BMJ. 326 (7404): 1419. PMID 12829553.
- "Tests start on pill that could lengthen millions of lives: Tablet aims to cut heart attack and stroke risk: Four-in-one drug could be sold for just $1 a month" Sarah Boseley, health editor The Guardian, Monday September 29 2008.
- Xavier D, Pais P, Sigamani A, Pogue J, Afzal R, Yusuf S (February 2009). "The need to test the theories behind the Polypill: rationale behind the Indian Polycap Study". Nat Clin Pract Cardiovasc Med. 6 (2): 96–7. PMID 19104516.
- Cannon CP (April 2009). "Can the polypill save the world from heart disease?". Lancet. 373 (9672): 1313–4. PMID 19339044.
- Gorman, Rachael Moeller. "The Polypill" Proto, Winter 2007