ORAL DISSOLVING STRIPS: AN EMERGING TREND IN THE PHARMACEUTICAL AND HEALTHCARE INDUSTRY

INTRODUCTION

The growth in administration technology has led to the development of novel delivery systems, especially in healthcare. One such novel system that has gained widespread popularity is Oral Dissolving Strips (“ODS”), also known as Oral Thin Strips. ODS are flexible strips, typically made from water-soluble polymers or film-forming materials, containing various active substances.1 The ODS market was valued at USD 2.9 billion in 2021 and is growing at a Compound Annual Growth Rate (“CAGR”) of 9.3% from 2022 to 2031.2 ODS are widely popular in the Fast-Moving Consumer Goods (“FMCG”) sectors as mouth fresheners, teeth whitening, and other oral care products offering a convenient way to maintain oral hygiene. While ODS have been predominantly used in the FMCG sector, they are also becoming popular in the life sciences industry.

This note examines the emerging trend of ODS use in the life sciences and pharmaceutical industry. 

ODS AND ITS EMERGING USE IN THE LIFE SCIENCES AND PHARMACEUTICAL INDUSTRY 

a) Nutraceuticals

In recent years, there has been an added focus on the general healthcare and nutrition in India. The private sector has launched various nutraceutical products, constituting 10% of the global market at USD 11 billion.3 A nutraceutical essentially indicates any product which has been derived from food sources to provide extra health benefits in addition to the basic nutritional value found in foods.4 Nutraceuticals such as dietary supplements are usually administered orally through concentrated liquids, capsules, powder, or pills.6 However, these modes of administration have often been labelled as inconvenient due to issues relating to swallowing of pills or capsules, or the requirement of water in cases of powders. 

To combat these issues, companies have started to look at ODS as a preferred method of administration. According to industry experts, ODS help nutrients enter the circulatory system directly and quickly and deliver a larger proportion of the active compound per dose without excipients.6 ODS strips containing essential vitamins and minerals have gained great traction in the market, with many companies introducing multivitamin ODS over traditional chewables and pills. Companies engaging in the manufacturing of ODS nutraceuticals in India have also been actively undertaking expansion and funding activities.7 The recent introduction of ODS-based nutraceuticals for women to address the issue of morning sickness and nausea during pregnancy, and cramps during periods showcases the improving popularity of ODS in India.8

b) Drug Manufacture

In addition to the nutraceutical sector, the drug manufacturing sector has also begun looking at ODS as a method of administration. The drug manufacturing industry stands at USD 516.48 billion, out of which India contributes close to USD 48.4 billion.9 Currently, around 60% of all drugs available commercially have to be taken orally.10 Much like in the case of nutraceuticals, ODS containing concentrated compounds of the drug provide for easy administration and faster entry into the circulatory system.11 ODS-containing drugs can be extremely useful in cases of adolescents, geriatrics, disabled, and bedridden patients, who may have trouble swallowing pills. 

While the advantages of ODS are significant, drug manufacturing companies are yet to introduce large-scale ODS products of generic medicines. Only a handful of pharmaceutical companies have forayed into ODS due to the high costs associated with manufacturing a novel drug delivery system. While the market for ODS drugs is growing at 9.1% CAGR, it is expected to reach a mere USD 4.274 billion by 2030. 12

LEGAL REGULATIONS GOVERNING ODS 

With the growing popularity of ODS worldwide as well as in India, there is an added focus on healthcare law surrounding ODS. Since ODS are a method of administration, they are governed by industry or sector-specific regulations. Therefore, ODS-based FMCG goods such as mouth fresheners are governed by the Food Safety and Standards Act, 2006, while ODS for cosmetics such as teeth cleaning and whitening are governed by the Drugs and Cosmetics Act, 1945 and the Cosmetics Rules, 2020. In cases of nutraceuticals using ODS, the provisions of the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016 (“Nutraceutical Regulations”) are applicable. ODS-based drugs are governed under the Drugs and Cosmetics Act, 1945 and the Drug Rules, 1945. 

It is important to note that though these provisions generally apply to ODS, none of the regulations have special provisions for ODS-based administration. If there is general compliance with the provisions of the respective regulations, manufacturers can make use of ODS. Though there is no mention of ODS in any Indian regulations in force, the government has realised its growing popularity, especially in the nutraceutical industry. The draft amendment to the Nutraceutical Regulations introduced by the government in 2022, provides ODS as a method of administration of all categories of nutraceuticals, except for foods specially meant for specific medical purposes.  13

Much like legal regulations in India, the United States of America (USA) and the United Kingdom (UK) also do not have any specific regulations governing ODS. The UK Medicines and Healthcare Products Regulatory Agency (MHRA), the UK’s healthcare regulator, is responsible for regulating medicines, including administration methods like ODS. The regulations governing ODS in the UK are primarily aligned with the regulations for medicinal products. While the Food and Drug Administration (FDA) in the USA has released specific guidelines on oral dissolving tablets,14 the same does not extend to ODS.

CONCLUSION

The convenience of ODS over powders, pills, and other modes of administration has led to their increasing popularity in recent years. Despite a bleak outlook on the ODS market size, it may be only a matter of time before they surpass the traditional modes of administration. The next step would be for governments to acknowledge the potential of ODS and pass effective legal regulations recognising their advantages as an administration method. 

[1] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3757902/

[2] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3757902/

[3] https://timesofindia.indiatimes.com/blogs/voices/exploring-the-surging-potential-of-indias-nutraceutical-industry/

[4] https://www.news-medical.net/health/What-are-Nutraceuticals.aspx

[5] https://www.news-medical.net/health/What-are-Nutraceuticals.aspx

[6] https://wellbeingnutrition.com/blogs/listing/oral-thin-strips#:~:text=Introducing%20Oral%20Thin%20Strips%20%E2%80%93%20a,the%20active%20compound%20per%20dose

[7]https://www.nutraingredients-asia.com/Article/2023/04/28/India-s-oral-strip-nutraceutical-firm-eyes-expansion-in-the-US-and-SEA#

[7]https://www.nutraingredients-asia.com/Article/2023/04/28/India-s-oral-strip-nutraceutical-firm-eyes-expansion-in-the-US-and-SEA#
https://www.businessinsider.in/business/startups/news/wellbeing-nutrition-raises-10-million-funding-by-hindustan-unilever/articleshow/96173686.cms.

[8]https://www.financialexpress.com/healthcare/wellness/nutrizoe-launches-dissolvable-oralstripsforpregnancy-periods-and-nausea/2818842/

[9]https://www.imarcgroup.com/indiapharmaceuticalmarket#:~:text=The%20India%20pharmaceutical%20market%20size,13.01%25%20during%202023%2D2028

[10]https://www.frontiersin.org/articles/10.3389/fphar.2021.618411/full#:~:text=Around%2060%25%20of%20established%20small,formulations%20intended%20for%20human%20use

[11]https://drugdev.com/oralthinfilmsmisconceptionsadvantageslimitationsaboutanemergingdrugdeliverysystem/#:~:text=OTFs%20are%20an%20attractive%20option,oromucosal%20and%2For%20sublingual%20absrption

[12]https://www.researchandmarkets.com/reports/5750434/oral-thin-film-drugs-market-size-market-share

[13] https://www.fssai.gov.in/upload/advisories/2022/03/6243ef28079ceDirection_Nutra_30_03_2022.pdf

[14] https://www.fda.gov/media/70877/download#:~:text=We%20generally%20recommend%20that%20the,justified%20based%20on%20product%20performance