Drug delivery via oral route is the gold standard in pharmaceutical market. Oral tablets are generally designed for release of drug into the gastrointestinal tract for quick absorption into the body circulation. Oral tablets are generally swallowed intact with water only with an exception of orally disintegrating tablets (ODT’s) and chewing tablet. Orally disintegrating tablets are drug containing solid unit dosage that rapidly disintegrates and dissolves in mouth within 60 seconds or less, without the requirement of water. In December 1996, US FDA (Food and Drug Administration) approved Claritin (loratadine), as the first ever orally disintegrating tablet which was a formation of Zydis ODT. Later, more two formations of Zydis ODT namely Klonopin (clonazepam) and Maxalt (rizatriptan), were FDA approved in December 1997 and June 1998 respectively. Orally disintegrating tablets can be swallowed and can also be dissolved in water before consumption. Orally disintegrating tablets are also called as rapid-dissolving, rapid-disintegrating, mouth-dissolving and orodispersible. Orally disintegrating tablet technology products entered the pharmaceutical market since 1980. Owing to the better and thorough understanding of the bio-chemical and physicochemical parameters by pharmaceutical scientists and better patient compliance, orally disintegrating tablets have gained considerable market. Orally disintegrating tablets have seen to be used as a preferred alternative over conventional tablets and capsules.
According to a research article published in world journal of pharmacy and pharmaceutical sciences, of all the tablets worldwide, over 90% of tablets are ingested by oral routes. Orally disintegrating tablets can be manufactured by many methods and techniques such as lyophilization or freeze drying, tablet molding, spray drying, mass-extrusion, phase transition, melt granulation, sublimation, cotton candy technology and direct compression method. Out of all the methods or technologies applied for production, direct compression method is the most preferred, cost-effective and also provides orally disintegrating tablets with adequate structural integrity. Of the total drug prescriptions, about two-third are dispensed as solid dosage forms, while 50 percent of these are dispensed as compressed tablets.
The major driver in ODT market is that the orally disintegrating tablets prevent several limitations faced in tablets and capsules such as chocking, bitter taste and swelling discomfort faced, especially in children and geriatric patients. Orally disintegrating tablet market has seen a steady growth and there is rapid expansion in product pipelines. Also, over the past decade, more patient-friendly, better taste and compliant dosage form has enhanced demand for oral disintegrating market. Its importance is recognized by both the academia and industry. While growing importance of oral disintegrating tablets has been marked recently when the term ‘Orodispersible Tablet’ was adopted by European Pharmacopoeia and has explained it as the tablet that disperses rapidly in mouth when placed on tongue, before swallowing.
Orally disintegrating tablet market faces some challenges like, difficulty in formulation of drugs with relatively high or large doses, such as formulation for ciprofloxacin antibiotic with high adult of 500mg tablet is found to be difficult. Thus, technologies applied for orally disintegrating tablets is limited by drug amount content in each unit dose, which should be less than 400mg and 60mg for insoluble and soluble drugs respectively. Other challenges include low mechanical strength of the orally disintegrating tablets due to its soft molded matrices or porosity; it requires special packaging and care to maintain proper stability as compared to other tablets and capsules, as orally disintegrating tablets are hygroscopic and require surfactants as well as solid buffers to optimize drug solubility; and some orally disintegrating tablets are costly.
ODT’s have opportunity to be used for peptide and protein based drug delivery systems and can also be combined with various drug carriers to develop controlled released ODT’s. With technological advancement increasing in development of orally disintegrating tablets, formulations containing pharmaceutical ingredient that is lipophilic active with help of new orally disintegrating tablets technology can provide great opportunities for growth in orally disintegrating tablets market.
Based on disease indications orally disintegrating tablet market is segmented into CNS diseases, gastrointestinal diseases and oncology. Amongst which central nervous system diseases segment holds the largest market. Drugs used in therapeutic intervention for gastro esophageal reflux disease (GERD), schizophrenia, Parkinson ’s disease, migraine, sleeping aids, etc., drives the market for CNS segment of orally disintegrating tablet market. While based on distribution channels, orally disintegrating tablet market is segmented into hospital pharmacies, retail pharmacies, drug stores, and retail pharmacies.
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On the basis of regional presence, global orally disintegrating tablet market is segmented into five key regions viz. North America, Latin America, Europe, Asia Pacific excluding Japan, Japan and Middle East & Africa. The key players in global orally disintegrating tablet market are Pfizer Inc., Eli Lilly and Company, Merck & Co., Inc., AstraZeneca, Bristol-Myers Squibb Company, GlaxoSmithKline plc, F. Hoffmann-La Roche Ltd, Johnson and Johnson services, Johnson Services, Inc., and Mission Pharmacal Company.
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