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Orally disintegrating tablet

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clonazepam ODT blister pack and tablet

An orally disintegrating tablet (ODT) is a drug dosage form available for a limited amount of over-the-counter(OTC) and prescription medications. ODTs differ from traditional tablets in that they are designed to be dissolved in the mouth rather than swallowed whole. The ODT serves as an alternative dosage form that offers an ease of use for patients that experience dysphagia. Dysphagia, or difficulty in swallowing is common among all age groups, and is observed in about 35% of the general population , and has been reported in up to 60% of elderly institutionalized population [1] [2], and 18-22% of all persons in long-term care facilities [3], many of whom are required to consume medications on a regular basis. This may lead to poor or even non-compliance with oral treatments and thus has a negative impact on the efficacy of certain medications. During the last decade ODTs have found their way into a variety of therapeutic markets. ODTs can now be found in over the counter (OTC) products, such as Claritin RediTabs, Alavert, Unisom SleepMelts, as well as prescription products such as Parcopa.

History

Tablets designed to dissolve on the buccal (cheek) mucous membrane were a precursor to the ODT. This dosage form was intended for drugs that yield low bioavailability through the digestive tract but are inconvenient to administer parenterally, such as steroids and narcotic analgesics.[4] Absorption through the cheek allows the drug to bypass the digestive tract for rapid systemic distribution. The first ODTs disintegrated through effervescence rather than dissolution, and were designed to make taking vitamins more pleasant for children.[5] This method was adapted to pharmaceutical use with the invention of microparticles containing a drug, which would be released upon effervescence of the tablet and swallowed by the patient.[6] Dissolution became more effective than effervescence through improved manufacturing processes and ingredients (such as the addition of mannitol to increase binding and decrease dissolution time).[7] Cima Labs in the U.S. and Takeda Pharmaceutical Company in Japan led the development of ODTs.

The first ODT form of a drug to meet FDA approval in the U.S. was Claritin (loratadine) in December 1996.[8] It was followed by Klonopin (clonazepam) in December 1997,[9] and Maxalt (rizatriptan) in June 1998.[10] The regulatory condition for meeting the definition of an orally disintegrating tablet is USP method 701 for Disintegration. This practice is under review by the FDA as the fast disintegration time of ODTs makes the Disintegration test too rigorous.

Manufacturing/Packaging

ODTs don’t necessarily require special manufacturing processes versus traditional tablets. ODTs are compressed at much lower forces (4 – 20 kN) than traditional tablets, but there is no additional challenge in this. However, since ODTs are compressed at very low forces due to the need to them to be soft enough to disintegrate rapidly in the mouth, issues of material sticking to the die walls can be challenging. Typically, as in most tablet blends, lubricants such as magnesium stearate are added to the blend to reduce the amount of material that may stick to the die wall. ODTs are manufactured much in the same way as traditional tablets, but differences in may be the use of disintegrating aids such as crospovidone and binders that aid in mouth feel such as microcrystalline cellulose. Primarily ODTs contain some form of sugar such as mannitol, which typically serves as the major diluent of the ODTs, and is also the primary contributor to the smooth and creamy mouth feel of most ODTs.

ODTs are available in HPDE bottles (Parcopa) or individually sealed in blister packs to protect the tablets from damage, moisture, and oxidation. Because ODTs are soft in nature, the ability to successfully package an ODT in a bottle is difficult. However, CIMA labs markets their Durasolv ODT as being able to be placed into bottle for commercial sale. CIMAs Orasolv is marketed for blisters only. While the differences between these two products are proprietary, the primary difference is expected to be the use of microcrystalline cellulose (MCC), such as Avicel PH101, in the Durasolv product. MCC serves multiple purposes in an ODT but in the case of CIMAs products, it serves primarily as a binder thereby increasing the internal strength of the tablet making it more robust for packaging in bottles.


ODTs currently available

Product Manufactured By/For Active ingredient Category Indication Intended Age Group
Abilify Discmelt[11] Otsuka America/Bristol-Myers Squibb aripiprazole Atypical antipsychotics Schizophrenia, Bipolar disorder, adjunct therapy for Major Depressive Disorder[11] 13 years+ for Schizophrenia, 10 years+ for Bipolar disorder, adults for MDD[11]
Alavert Quick Dissolving Tablets Wyeth Loratadine Anti-histamines Allergy 6 years+
Allegra ODT Sanofi Aventis Fexofenadine Anti-histamines Allergic rhinitis, Urticaria[12] 6-11 years[12]
Aricept ODT Eisai Co. Donepezil Acetylcholinesterase inhibitors[13] Alzheimer's disease[13] adults[13]
Benadryl FastMelt Pfizer Diphenhydramine Anti-histamines Allergy 6 years+
Calpol Fast Melts McNeil Healthcare UK Paracetamol Analgesics Pain 6 years+
Clarinex RediTabs Schering-Plough Desloratadine Anti-histamines Allergy 6 years+
Claritin RediTabs Schering-Plough Loratadine Anti-histamines Allergy 6 years+
Clonazepam ODT Par Pharmaceutical Clonazepam Benzodiazepines Anxiety, Panic Disorder, Seizure Disorders[14] infants+[14]
FazaClo AzurPharma Clozapine Antipsychotics treatment-resistant Schizophrenia[15] adults[15]
Jr. Tylenol Meltaways McNeil Consumer Healthcare acetaminophen Analgesics, Anti-pyretics Pain, Fever 6 years+
Klonopin Wafers[16] Roche clonazepam Benzodiazepines Panic Disorder, Seizure Disorders[16] infants+ for seizure disorders, adults for Panic Disorder[16]
Loratadine Redidose Ranbaxy loratadine Antihistamines Allergy 6 years+
Maxalt-MLT Merck & Co. Rizatriptan Triptans/Serotonin agonists acute Migraine[17] 18 years+[17]
Mirtazapine ODT Teva Pharmaceuticals Mirtazapine Antidepressants Major Depressive Disorder[18] adults[18]
Nurofen Meltlets Reckitt Benckiser Ibuprofen NSAIDs Pain, Fever, Inflammation 12 years+
Ondansetron ODT Teva Pharmaceuticals Ondansetron Antiemetics Nausea, Vomiting[19] 4 years+[19]
Orapred ODT Sciele Pharma Prednisolone Corticosteroids Asthma, severe Allergy, Hemolytic anaemia, Stevens-Johnson syndrome, certain types of Tuberculosis; acute treatment of arthritis, bursitis, COPD, Leukemia, Lupus, Multiple sclerosis, Ulcerative colitis[20] adults and children weighing over 44lbs/20.1kg[20]
Parcopa Schwarz Pharma Carbidopa/levodopa DDC inhibitors [carbidopa] Parkinson's disease[21] adults[21]
Prevacid SoluTab Takeda Pharmaceuticals Lansoprazole Proton pump inhibitors[22] Gastro-oesophageal Reflux Disease (GERD), Ulcers[22] 1 year+[22]
Remeron SolTab Schering-Plough Mirtazapine Antidepressants Major Depressive Disorder[18] adults[18]
Risperdal M-Tab Janssen Risperidone Atypical antipsychotics Schizophrenia, Bipolar disorder, Irritability associated with Autistic disorder[23] 13 years+ for Schizophrenia, 10 years+ for Bipolar disorder, 5 years+ for Autism[23]
UNISOM SleepMelts Chattem Diphenhydramine Anticholinergic Nighttime Sleep Aid Adults and children 12 years+[24]
Zelapar Valeant Pharmaceuticals Int'l Selegiline Monoamine oxidase inhibitors (MAOIs)[25] adjunct therapy in Parkinson's disease[25] adults[25]
Zofran ODT GlaxoSmithKline Ondansetron Antiemetics Nausea, Vomiting[19] 4 years+[19]
Zomig-ZMT AstraZeneca Zolmitriptan Triptans/Serotonin agonists Migraine[26] adults[26]
Zyprexa Zydis Eli Lilly and Company Olanzapine Atypical antipsychotics Bipolar disorder, Schizophrenia[27] adults [27]

ODTs under development

Product Manufacturer Active ingredient Category Indication Intended Age Group
Citalopram ODT[28] Biovail[28] Citalopram SSRIs Major Depressive Disorder[29]
Metoclopramide Zydis[30] Salix Pharmaceuticals[30] Metoclopramide Dopamine receptor antagonists short-term therapy for GERD, acute diabetic gastric stasis[30] adults[30]
Reglan ODT[31] Schwarz Pharma[31] Metoclopramide Dopamine receptor antagonists short-term therapy for GERD, acute diabetic gastric stasis[31] adults[31]
Tramadol/Acetaminophen ODT[28] Biovail[28] Tramadol/Acetaminophen Opioid analgesic [Tramadol][32] Pain[28] adults[32]
Zolpidem ODT[28] Biovail[28] Zolpidem Nonbenzodiazepine Hypnotics[33] Sleep disorders[28] adults[33]

See also

References

  1. ^ Sastry, S. et al., Pharm. Sci. & Tech. Today 3: 138-145, 2000.
  2. ^ Groher ME, Bukatman MS. The prevalence of swallowing disorders in two teaching hospitals. Dysphagia. 1: 3-6, 1986.
  3. ^ Layne KA, Losinski DS, Zenner PM, Ament JA. Using the Fleming index of dysphagia to establish prevalence. Dysphagia. 4: 39-42, 1989.
  4. ^ Fast dissolving buccal tablet, 1991 {{citation}}: Unknown parameter |country-code= ignored (help); Unknown parameter |inventor1-first= ignored (help); Unknown parameter |inventor1-last= ignored (help); Unknown parameter |patent-number= ignored (help)
  5. ^ Pediatric effervescent dosage form, 1993 {{citation}}: Unknown parameter |country-code= ignored (help); Unknown parameter |inventor1-first= ignored (help); Unknown parameter |inventor1-last= ignored (help); Unknown parameter |inventor2-first= ignored (help); Unknown parameter |inventor2-last= ignored (help); Unknown parameter |inventor3-first= ignored (help); Unknown parameter |inventor3-last= ignored (help); Unknown parameter |patent-number= ignored (help)
  6. ^ Effervescent dosage form with microparticles, 1993 {{citation}}: Unknown parameter |country-code= ignored (help); Unknown parameter |inventor1-first= ignored (help); Unknown parameter |inventor1-last= ignored (help); Unknown parameter |inventor2-first= ignored (help); Unknown parameter |inventor2-last= ignored (help); Unknown parameter |inventor3-first= ignored (help); Unknown parameter |inventor3-last= ignored (help); Unknown parameter |patent-number= ignored (help)
  7. ^ Fast dissolving dosage forms, 1990 {{citation}}: Unknown parameter |country-code= ignored (help); Unknown parameter |inventor1-first= ignored (help); Unknown parameter |inventor1-last= ignored (help); Unknown parameter |inventor2-first= ignored (help); Unknown parameter |inventor2-last= ignored (help); Unknown parameter |inventor3-first= ignored (help); Unknown parameter |inventor3-last= ignored (help); Unknown parameter |inventor4-first= ignored (help); Unknown parameter |inventor4-last= ignored (help); Unknown parameter |patent-number= ignored (help)
  8. ^ FDA Drug Details for Claritin RediTabs
  9. ^ FDA Drug Details for Klonopin Wafer
  10. ^ FDA Drug Details for Maxalt-MLT
  11. ^ a b c Abilify Prescribing Information
  12. ^ a b Allegra Prescribing Information
  13. ^ a b c Aricept Prescribing Information
  14. ^ a b Clonazepam ODT Prescribing Information
  15. ^ a b FazaClo Prescribing Information
  16. ^ a b c Klonopin Prescribing Information
  17. ^ a b Maxalt Prescribing Information
  18. ^ a b c d Remeron SolTob Prescribing Information
  19. ^ a b c d Zofran Prescribing Information
  20. ^ a b Orapred Prescribing Information
  21. ^ a b Parcopa Prescribing Information
  22. ^ a b c Prevacid Prescribing Information
  23. ^ a b Risperdal Prescribing Information
  24. ^ Unisom Drug Facts
  25. ^ a b c Zelapar Prescribing Information
  26. ^ a b Zomig Prescribing Information
  27. ^ a b Zyprexa Prescribing Information
  28. ^ a b c d e f g h Biovail Product Pipeline
  29. ^ Citalopram Prescribing Information
  30. ^ a b c d Salix Pharmaceuticals Acquires Patent–Protected Metoclopramide–Zydis
  31. ^ a b c d FDA Drug Approval for Reglan ODT
  32. ^ a b Ultracet Prescribing Information
  33. ^ a b Ambien Prescribing Information
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