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RUBIODT ®




Orally disintegrating tablets (ODT) provide an “age-appropriate dosage form” for patients having difficulty in swallowing conventional oral dosage forms. Established systems of manufacturing ODTs involve complex, tedious and expensive manufacturing processes. RubiODT® is a novel technology for developing robust ODT formulations which disintegrate in oral cavity in less than 30 secs and provide pleasant, smooth and creamy mouth-feel even with bitter APIs. Tablets can be manufactured and packaged using conventional equipment using this technology.

Potential Drug Candidates for RubiODT®
Your Molecule ; Our Technology

Drug substances which exhibit one or more of following properties are potential candidates for RubiODT®

  • For pediatric and/or geriatric dosing
  • Used by people “On the move”
  • Bitter and obnoxious taste
  • Opportunity of LCM

RubiODT® technology is based on direct compression of (taste-masked) drug substance with excipients. It involves use of a special co-processed excipient (available commercially as PanExceaODT® from Avantor Performance Materials. This excipient facilitates rapid disintegration and dispersion of the tablet in the oral cavity while providing good taste and texture. The unique particle geometry and the composition of RubiODT® enable increased API loading capacity. RubiODT® is suitable for drugs having various doses up to 650 mg, different solubility profiles and bitter taste.

Rubicon has extensive experience of working on various taste-masking technologies including its own RubiCoat® taste masking technology. The RubiODT® technology can also deliver drug in a controlled or sustained or delayed release manner. It employs conventional equipment for manufacturing and packaging.

IP status

The basic technology is protected by patent applications filed in various countries. Additional patent applications have also been filed for expanding the scope of RubiODT® technology.

Schematic


Key attributes

  • Rapid disintegration
  • Pleasant and creamy mouthfeel
  • Suitable for high dose actives
  • Suitable for bitter or unpleasant molecules
  • Can be used for controlled or delayed drug release ODT formulations
  • Employs GRAS listed and Pharmacopoeial ingredients
  • Conventional method of manufacture
  • Good stability profile
  • Desired stability profiles

Acetaminophen fast melt

Acetaminophen (Paracetamol, APAP) is a high dose extremely bitter molecule. Acetaminophen was taste masked using RubiCoat technology and incorporated into a fastmelt formulation using RubiODT® technology. Currently 80 mg, 125 mg, 160 mg, 250 mg and 500 mg strengths have been developed for this product. Tablets disintegrate rapidly with a pleasant taste and extremely good mouthfeel. The developed formulation is stable and has been scaled up to 30 Kg scale so far.

Other ODTs developed by Rubicon are

Cough, Cold &Anti-allergy

Cetirizine, Levocetirizine, Loratadine, Dextromethorphan, Guaiphenesin, Chlorpheniramine Maleate, Diphenhydramine HCl, Phenylephrine HCl

Anti-inflammatory / Analgesic

Paracetamol, Aspirin, Ibuprofen, Flurbiprofen

CNS Drugs

Ropinirole HCl, Memantine HCl, Donepezil HCl

Anti-Emetic

Ondansetron

Challenges and achievements

  • Extremely bitter taste of the API
  • High dose
  • Achieved rapid disintegration
  • No retardation in drug release
  • Robust and easy to handle tablets