Orally disintegrating tablet
An orally disintegrating tablet or orally dissolving tablet (ODT) is a drug dosage form available for a limited range of over-the-counter (OTC) and prescription medications. ODTs differ from traditional tablets in that they are designed to be dissolved on the tongue rather than swallowed whole.[1][2][3][4][5][6][7][8][9][10][11] The ODT serves as an alternative dosage form for patients who experience dysphagia (difficulty in swallowing) or for where compliance is a known issue and therefore an easier dosage form to take ensures that medication is taken. Common among all age groups, dysphagia is observed in about 35% of the general population, as well as up to 60% of the elderly institutionalized population [12][13] and 18-22% of all patients in long-term care facilities [14] ODTs may have a faster onset of effect than tablets or capsules, and have the convenience of a tablet that can be taken without water. During the last decade, ODTs have become available in a variety of therapeutic markets, both OTC and by prescription.
History
Tablets designed to dissolve on the buccal (cheek)
The first ODT form of a drug to get approval from the
Manufacturing/packaging
The processes used to manufacture orally disintegrating tablets include loose compression tabletting, a process which is not very different than the manufacturing method used for traditional tablets and
ODTs are available in HPDE bottles (Parcopa) or individually sealed in
ODTs currently or previously available
Brand name | Manufactured by/for | Generic available[23] | Active ingredient | Category | Indication | Intended age |
---|---|---|---|---|---|---|
Abilify Discmelt[24] | Bristol-Myers Squibb
|
yes | aripiprazole | Atypical antipsychotics | Schizophrenia[24] | 13 years+[24] |
Bipolar disorder[24] | 10 years+[24] | |||||
Adjunct therapy for major depressive disorder[24] | adults[24] | |||||
Adzenys XR-ODT | Neos Therapeutics | no | amphetamine | Amphetamines, Stimulants | Attention deficit hyperactivity disorder | 6 years+[25] |
Alavert Quick Dissolving Tablets | Wyeth | yes | loratadine | Antihistamines | Allergy | 6 years+ |
Allegra ODT | Sanofi Aventis
|
yes | fexofenadine | Antihistamines | Urticaria[1]
|
6–11 years[1][26] |
Aricept ODT | Eisai Co.
|
yes | donepezil | Acetylcholinesterase inhibitors[2] | Alzheimer's disease[2] | adults[2] |
Benadryl FastMelt | Pfizer | yes | diphenhydramine | Antihistamines
|
Allergy | 6 years+ |
Calpol Fast Melts | McNeil Healthcare UK | yes | paracetamol | Analgesics | Pain | 6 years+ |
Cipralex MELTZ | Lundbeck | yes[27] | escitalopram | SSRIs, Antidepressant
|
Major depressive disorder, Generalized anxiety disorder, Obsessive–compulsive disorder | adults[28] |
Clarinex RediTabs | Schering-Plough | yes | desloratadine | Antihistamines | Allergy | 6 years+ |
Claritin RediTabs | Bayer | yes | loratadine | Antihistamines | Allergy | 6 years+ |
DDAVP Melt | Ferring Pharmaceuticals | desmopressin | Antidiuretic | Central diabetes insipidus
|
5 years+[29] | |
Edluar | Meda AB | yes | zolpidem | Nonbenzodiazepine Hypnotics | Short-term treatment of insomnia[30] | adults |
Etizest MD | Consern | etizolam | Benzodiazepine analog/thienotriazolodiazepine | Short-term treatment of anxiety and insomnia | ||
FazaClo | AzurPharma | yes | clozapine | Antipsychotics | Treatment-resistant schizophrenia[31] | adults[31] |
Fluimucil | Alpex Pharma SA / Zambon Group | N-acetylcysteine | Mucolytic
|
Cold and Cough | 16 years+ | |
Jr. Tylenol Meltaways | McNeil Consumer Healthcare | yes | acetaminophen
|
Analgesics, Antipyretics | Pain, Fever | 6 years+ |
Kemstro | UCB Inc. | no | baclofen | Muscle relaxant, Antispastic | ||
Klonopin Wafers[32] | Roche
|
yes | clonazepam | Benzodiazepines, Anticonvulsant, Anxiolytics | Seizure disorders[32]
|
infants+[32] |
Panic disorder[32] | adults[32] | |||||
Lamictal ODT | GlaxoSmithKline
|
yes | lamotrigine | Anticonvulsant, Mood stabilizer | Seizure disorders
|
2 years+ |
Bipolar I disorder | adults | |||||
Maxalt-MLT | Merck & Co. | yes | rizatriptan | Triptans, Serotonin agonists
|
Migraine[3] | adults[3] |
meloxicam orodispersible tablets | Alpex Pharma Ltd (UK); Fontus Health Ltd (UK) | meloxicam | NSAIDs
|
Osteoarthritis, Rheumatoid arthritis, Ankylosing spondylitis | 16 years+ | |
Niravam | Schwarz Pharma
|
yes | alprazolam | Benzodiazepines, Anxiolytics | Anxiety disorder, Panic disorder | adults[33] |
Nocdurna | Ferring Pharmaceuticals | desmopressin | Antidiuretic | Nocturia | adults[34] | |
NuLev | Alaven Pharmaceutical | hyoscyamine | anticholinergic / antispasmodic | Peptic ulcer , Symptoms of various gastrointestinal and urinary disorders
|
2 years+ | |
Nurofen Meltlets | Reckitt Benckiser
|
ibuprofen | NSAIDs
|
Pain, Fever, Inflammation | 12 years+ | |
Orapred ODT | Sciele Pharma | yes | prednisolone | Corticosteroids | Hemolytic anaemia, Stevens–Johnson syndrome, Certain types of tuberculosis; acute treatment of arthritis, Bursitis, COPD, Leukemia, Lupus, Multiple sclerosis, Ulcerative colitis[6]
|
adults and children weighing over 44 lbs/20.1 kg[6] |
Parcopa | Schwarz Pharma
|
yes | carbidopa/levodopa | Dopamine precursor [levodopa]
|
Parkinson's disease[7] | adults[7] |
Pepcid RPD | Scherer DDS / Merck | yes | famotidine | Histamine H2-receptor antagonists[35]
|
gastric ulcer, gastroesophageal reflux disease , pathological hypersecretory conditions
|
adults |
Prevacid SoluTab | Takeda Pharmaceuticals
|
yes | lansoprazole | Proton pump inhibitors[8]
|
Ulcers[8]
|
1 year+[8] |
Propulsid Quicksolv (withdrawn) | Janssen Pharma
|
no | cisapride | Gastroprokinetic agent
|
||
Reglan ODT | Schwarz Pharma[36]
|
yes | metoclopramide | Dopamine receptor antagonists
|
short-term therapy for GERD, acute diabetic gastric stasis[36] | adults |
Remeron SolTab | Merck & Co. | yes | mirtazapine | Antidepressants | Major depressive disorder[4] | adults[4] |
Risperdal M-Tab | Janssen Pharma
|
yes | risperidone | Atypical antipsychotics | Schizophrenia[9] | 13 years+[9] |
Bipolar disorder[9] | 10 years+[9] | |||||
autistic disorder[9]
|
5 years+[9] | |||||
Rybix ODT | Victory Pharma | yes[37] | tramadol | Opioid, SNRI | Pain | 16 years+ |
Saphris | Merck & Co. | no[38] | asenapine | Atypical antipsychotics | Schizophrenia, Bipolar disorder | adults |
Staxyn | Bayer Healthcare | yes | vardenafil | Phosphodiesterase 5 (PDE5) inhibitor | Erectile dysfunction | adult males |
Striant Buccal | Columbia Laboratories | no | testosterone | Androgen, Steroid hormone | Hypogonadism (Low testosterone) | adult males |
Suboxone tablets (also available as dissolvable film)
|
Reckitt Benckiser
|
no | Buprenorphine/Naloxone | semi-synthetic opioid partial opioid agonist & inverse opioid antagonist
(Naloxone is included because it deters abuse. Naloxone is poorly absorbed into the body when used by mouth or as an ODT. However, when the pill is crushed and/or filtered and injected intravenously , naloxone blocks the effects of buprenorphine.)
|
Opioid addiction
|
adults |
Suprenza | Alpex Pharma / Citius | no | phentermine | Amphetamines, Anorectic | Weight control
|
adults |
Ultram ODT | Ortho-McNeil Pharmaceutical | yes[37] | tramadol | Opioid, SNRI | Pain | 17 years+[39] |
Unisom SleepMelts | Chattem | yes | diphenhydramine | Antihistamines, Hypnotic | Insomnia | 12 years+[40] |
Vometa FT | Dexamedica | domperidone | Antiemetics, Prokinetic agent | Dyspepsia, Bloating, GERD, Gastroparesis | 12 years+ | |
Zelapar | Valeant Pharmaceuticals International
|
no | selegiline | Monoamine oxidase B inhibitors (MAOBIs) | Adjunct therapy in parkinson's disease | adults[41] |
Zofran ODT | GlaxoSmithKline
|
yes | ondansetron | Antiemetics | Nausea, Vomiting[5] | 4 years+[5] |
Zomig-ZMT | AstraZeneca | yes | zolmitriptan | Triptans, Serotonin agonists
|
Migraine[11] | adults[11] |
Zyprexa Zydis | Eli Lilly and Company | yes | olanzapine | Atypical antipsychotics | Bipolar disorder, Schizophrenia[42] | adults [42] |
Zyrtec | Johnson & Johnson Consumer Inc., | yes | cetirizine | Antihistamines | Allergy[43] |
Advantages of ODTs
Ved Parkash et al. note the following advantages of ODTs:
- they are easy to consume and as such are convenient for such patients as "the elderly, stroke victims, bedridden patients, patients affected by kidney failure, and people who refuse to swallow, such as pediatric, geriatric, and psychiatric patients";
- increased bioavailability (rapid absorption) due to pregastric absorption;
- don't require water to consume and thus suitable for "patient compliant for disabled, bedridden patients, and for travelers and busy people who do not always have access to water";
- good mouth feel;
- improved safety due to low risk of choking or suffocation during oral administration.[44]
Disadvantages of ODTs
Ved Parkash et al. lists the following disadvantages of ODTs:
- unpleasant taste;
- cost-intensive production process;
- lack of physical resistance in standard blister packs;
- limited ability to incorporate higher concentrations of active drug.[44]
ODTs under development
Brand name (generic version) |
Manufacturer | Active ingredient | Category | Indication | Intended age |
---|---|---|---|---|---|
citalopram ODT[45] | Biovail[45] | citalopram | SSRIs, Antidepressant
|
Major depressive disorder[46]
|
|
tramadol/acetaminophen ODT[45] | Biovail[45] | acetaminophen
|
Opioid / non-opioid analgesic[47] | Pain[45] | adults[47] |
See also
- Phagophobia - fear of swallowing
- Pnigophobia - fear of choking
- Sugar alcohol - a family of chemicals common in ODTs to enhance the mouth feel of the tablet as it disintegrates
References
- ^ a b c Allegra Prescribing Information
- ^ a b c d "Aricept Prescribing Information" (PDF). Archived from the original (PDF) on 2008-09-10. Retrieved 2009-01-10.
- ^ a b c Maxalt Prescribing Information
- ^ a b c "Remeron SolTob Prescribing Information" (PDF). Archived from the original (PDF) on 2016-03-03. Retrieved 2009-01-10.
- ^ a b c "Zofran Prescribing Information" (PDF). Archived from the original (PDF) on 2014-02-02. Retrieved 2009-01-09.
- ^ a b c Orapred Prescribing Information
- ^ a b c Parcopa Prescribing Information
- ^ a b c d "Prevacid Prescribing Information" (PDF). Archived from the original (PDF) on 2009-09-20. Retrieved 2009-01-09.
- ^ a b c d e f g "Risperdal Prescribing Information" (PDF). Archived from the original (PDF) on 2009-01-06. Retrieved 2009-01-10.
- ^ "Zelapar Prescribing Information" (PDF). Archived from the original (PDF) on 2008-05-09. Retrieved 2009-01-09.
- ^ a b c "Zomig Prescribing Information" (PDF). Archived from the original (PDF) on 2015-02-18. Retrieved 2009-01-09.
- ^ Sastry, S. et al., Pharm. Sci. & Tech. Today 3: 138-145, 2000.
- ^ Groher ME, Bukatman MS. The prevalence of swallowing disorders in two teaching hospitals. Dysphagia. 1: 3-6, 1986.
- ^ Layne KA, Losinski DS, Zenner PM, Ament JA. Using the Fleming index of dysphagia to establish prevalence. Dysphagia. 4: 39-42, 1989.
- ^ US 5073374, Mccarty, John A., "Fast dissolving buccal tablet", published 1991-12-17
- ^ US 5223264, Wehling, Fred; Schuehle, Steve & Madamala, Navayanarao, "Pediatric effervescent dosage form", published 1993-06-29
- ^ US 5178878, Wehling, Fred; Schuehle, Steve & Madamala, Navayanarao, "Effervescent dosage form with microparticles", published 1993-01-12
- ^ US 4946684, Blank, Robert G.; Mody, Dhiraj S. & Kenny, Richard J. et al., "Fast dissolving dosage forms", published 1990-08-07
- ^ FDA Drug Details for Claritin RediTabs
- ^ FDA Drug Details for Klonopin Wafer
- ^ FDA Drug Details for Maxalt-MLT
- ^ FDA Guidance for Industry Orally Disintegrating Tablets
- ^ "Approved Drug Products with Therapeutic Equivalence Evaluations" (PDF). Food and Drug Administration (36 ed.). 2016. Retrieved April 4, 2016.
- ^ a b c d e f g Abilify Prescribing Information Archived 2010-03-31 at the Wayback Machine
- ^ "Adzenys XR-ODT Prescribing Information" (PDF). Food and Drug Administration. January 2016. Retrieved 14 March 2016.
- ^ "Allegra - FDA prescribing information, side effects and uses". www.drugs.com. Retrieved 2016-04-04.
Allegra ODT is intended for use only in children 6 to 11 years of age.
- ^ "Product Monograph: Act Escitalopram ODT" (PDF). Health Canada. 25 October 2016. Retrieved 16 August 2018.
- ^ "Product Monograph: Cipralex and Cipralex METLZ" (PDF). Health Canada. 9 June 2016. Retrieved 16 August 2018.
- ^ "Product Monograph: DDAVP Melt" (PDF). Ferring Pharmaceuticals Canada. 17 December 2015. Archived from the original (PDF) on 14 March 2016. Retrieved 14 March 2016.
- ^ Edluar Prescribing Information
- ^ a b FazaClo Prescribing Information
- ^ a b c d e "Klonopin Prescribing Information" (PDF). Archived from the original (PDF) on 2007-03-17. Retrieved 2009-01-10.
- ^ "Niravam - FDA prescribing information, side effects and uses".
- ^ "Product Monograph: Nocdurna" (PDF). 3 September 2014. Retrieved 14 March 2016.
- ^ "Pepcid (label)" (PDF). Food and Drug Administration. Retrieved April 4, 2016.
- ^ a b FDA Drug Approval for Reglan ODT
- ^ a b "FDA Issues Approval Letter For Tramadol ODT, for Moderate to Severe Pain". DocGuide. Retrieved 2016-04-04.
- ^ "Generic Saphris Availability - Drugs.com". www.drugs.com. Retrieved 2016-04-04.
- ^ "Ultram ODT - FDA prescribing information, side effects and uses". www.drugs.com. Archived from the original on 2016-04-04. Retrieved 2016-04-04.
- ^ "Unisom Drug Facts". Archived from the original on 2016-03-04. Retrieved 2009-01-14.
- ^ "Zelepar Prescribing Information" (PDF). July 2014. Retrieved 14 March 2016.
- ^ a b Zyprexa Prescribing Information
- ^ "ZYRTEC® Dissolve Tabs". ZYRTEC®. Retrieved 2016-04-04.
- ^ PMID 22247889.
- ^ a b c d e "Biovail Product Pipeline". Archived from the original on 2009-09-15. Retrieved 2009-01-10.
- ^ Citalopram Prescribing Information
- ^ a b "Ultracet Prescribing Information" (PDF). Archived from the original (PDF) on 2011-06-05. Retrieved 2009-01-10.