Unmet Therapeutic Need
Extended and controlled release systems are very common due to their potential therapeutic benefits. Many of these systems employ polymers that have pH- dependent swelling or pH-dependent solubility characteristics. These factors result in formulations which have either a significant food effect or undesirable inter-subject variability leading to sub-optimal performance. RubiERT® is a novel controlled release technology which provides a non-swelling dosage form with pH-independent drug release. Inclusion of a pH-dependent release retardant in the combination provides unique, but predictable, in-vitro and in-vivo release profiles, which are unparalleled by other commonly employed controlled release.
Potential Drug Candidates for RubiERT®
Your Molecule ; Our Technology
Drug molecules which require
- Lower frequency of administration
- Reduced side effects Less fluctuations in plasma concentrations
- Release profiles which are difficult to reproduce with other technologies
- Opportunity for LCM
The technology involves use of a combination of a non-swelling, pH-dependent release retardant and a non-swelling pH-independent release retardant and yet provides a pH-independent drug release profile. By employing these polymers in different ratios it is possible to arrive at various release profiles, such as near zero order profile, a profile with a lag time, etc. Further the dependence of drug release on pH can also be manipulated by varying the concentration of pH-dependent release retardant. The release retardants employed are GRAS listed and the manufacturing processes are conventional.
The basic technology is protected by patent applications filed in various countries. Additional patent applications have also been filed for expanding the scope of RubiERT® technology.
- Applicable to drugs having different effective doses
- Adaptability for drugs with different aqueous solubilities
- Different release profiles achievable
- Possible to develop multiple strength formulations
- Pharmacopoeial and GRAS listed excipients
- Conventional, robust method of manufacture
- Desired stability profile
Different release profiles of an analgesic using RubiERT® technology
The selected model drug was an analgesic drug with high aqueous solubility. The drug was treated with a pH-dependent release retardant and blended with other excipients including pH-independent release retardant. The concentrations as well as ratios of release retardants were varied to achieve different release profiles. The drug dissolution behaviour was studied in a USP II apparatus using pH-change dissolution media. RubiERT® thus provided a simple, stable extended release formulation with 4-16 hours release profiles.
Challenges and achievements
By manipulating the concentrations of release retardants it is possible to achieve unique drug release profiles.