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RUBISRT ®




Flexible sustained release system with different release profiles

A number of marketed sustained release systems are based on swelling/gelling polymers (typically cellulose-based) which may have a significant food effect or inter-subject variability. Moreover, typically these systems are protected by an umbrella of patents, making development of generic versions very challenging. Rubicon has developed RubiSRT® system which offers a non-swelling dosage form with pH-independent drug release. The technology helps in developing patent non-infringing generic products and offers more predictable in-vivo behaviour.

Potential Drug Candidates for RubiReten®
Your Molecule ; Our Technology

Drug substances which require

  • less fluctuations in plasma concentrations
  • reduced side effects
  • lower frequency of administration
  • A patent non-infringing generic version
  • Release profiles which are difficult to reproduce with other technologies

The technology involves use of a unique combination of non–swelling polymeric and non-polymeric release retardants. Both kinds of release retardants exhibit pH-independent behavior. Due to non swelling nature of the release retardants, the dosage form retains its size throughout the drug release period and provides predictable in-vivo transit times. Further the pH-independent nature provides a better in-vitro/in-vivo-correlation. By employing these release retardants in different ratios, it is possible to develop different release profiles such as zero order, first order, Higuchi kinetics etc. This flexibility helps to generate a unique in-vitro release profile or alternatively match the profile of a reference product. The Technology has been successfully scaled-up to a 100,000 tablet scale.

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 RubiSRT® technology.

Schematic

Key attributes

  • Applicable to drugs having different effective doses
  • Adaptability for drugs with different aqueous solubilities
  • Different release profiles achievable
  • Possible to develop multiple strength formulations with potential for biowaiver
  • Pharmacopoeial and GRAS listed excipients
  • Conventional, ribust method of manufacture
  • Desired stability profile

Sustained release (SR) tablets of an antiparkinson’s agent using RubiSRT® technology. Antiparkinson’s agent’s SR tablets are designed for once daily dosing with a simpler and faster titration schedule. The drug employed is an extremely unstable molecule and selection of inactive ingredients and process of manufacturing are critical to the development of a stable product. A robust, stable, formulation of multiple strengths was developed. The developed product was shown to be bioequivalent to the currently marketed controlled release product.

RubiSRT® thus provided a simple, stable matrix controlled release formulation equivalent to a complex marketed formulation.

Challenges and achievements

  • Developed product was bioequivalent to a complex marketed formulation