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Intec's Accordion Pill is frequently a solution of choice for drugs that are characterized by:
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Frequent dosing
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Significant ADR due to fluctuations in plasma levels
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Low bioavailability
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Need for all night coverage
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Action site localized in the GI tract
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Pharmacological rationale to reduce exposure in the distal GI region
Examples (partial list):
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Amino Acids Analogs (e.g., various drugs for CNS disorders)
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Small Peptide Peptidomimetics (e.g., cardiovascular drugs, such as ACE inhibitors, ARB blockers)
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Peptides
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Beta-lactams and Cephalosporins (antibiotics)
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Local gastrointestinal therapeutics (e.g., drugs for GI infections, obesity, IBD, GERD, anti-emetic)
The proprietary Accordion Pill enables an improved product life cycle management (LCM) as well as an efficient platform to improve drug candidates.
Intec offers potential partners rapid human proof-of-concept (POC), to demonstrate the superiority of their specific drugs when administered with the Accordion Pill, in comparison with the current, marketed versions of these drugs.
| Stage |
1.
Formulation Development |
2.
Scale-up & Production |
3.
Batch Release |
4.
Human POC | Overall Duration |
| Activity |
Development of Accordion Pill with your drug, with desired release profile |
Scale up & production for human POC, in Intec’s cGMP pilot production site |
POC study stability and QC/QA batch release |
PK human study: Accordion Pill drug vs. the existing, marketed drug |
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| Outcome |
In vitro dissolution profile |
Bio batch for human POC |
COA Stability report |
Pharmacokinetic profiles |
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| Duration |
3-4 months |
2 months |
1 months |
3 months
including bioanalysis |
9-10 months |
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