Office:
#B201, MBR Shangri La Mysore Road, Kengeri, Bengaluru- 560060, Karnataka
Lab:
IDRS Labs Pvt. Ltd. 235-H, Phase 3, Bommasandra Industrial Area, Hosur Road, Bengaluru - 560099, Karnataka
More than 40% of anticancer drugs, are poorly water-soluble, hence these drug’s results in poor bioavailability (BA) and high intra- and inter-individual pharmacokinetic variability. Solid dispersion by HME improves solubility and being a contained system there is low dust formation and hence safe for handling of high potent drugs.
We provide services for Product development by Twin screw processor for
Product Development (composition & Process) Service and Activities:
| Type of Development | Development Activities | Description of Activities | No. of Trials | Total material Qty. required* | |
|---|---|---|---|---|---|
| End-to-End | Partial | Feasibility or POC trials | Assess technical feasibility (Screening of polymer/s, excipients and process condition) |
5-10 | 0.1 – 1 kg |
| Prototype or trials | Develop prototypes formulations by HME, meeting the broad specification | 10-30 | 2 – 5 kg | ||
| Long run Trials | Understanding the stability of the process run. (Run time 1-3 hrs) | 1-3 | 1-6 kg | ||
| Pilot bio batch and stability | Manufacturing of the Pilot bio batch at identified manufacturing site | 1 – 3 | 1 – 5 kg | ||
| Optimization Trial | DoE run to define design space for composition and process | 6-20 | 1 – 2 kg | ||
| Scaleup | Scale up and Engineering batch |
Scale up on same scale of HME (long run) or higher scale HME at commercial scale |
5-10 | Depends on scale of the HME machine | |
| Commercial manufacturing | Exhibit batch manufacturing at identified manufacturing site | 3 | Depends on scale of the HME machine | ||
* The drug loading would be 10 – 70 based on the product requirement
Process Development Service and Activities:
| Sr. no. | Development Activities | Description of Activities | No. of Trials | Total material Qty. required* |
|---|---|---|---|---|
| 1 | Feasibility or POC trials | Feasibility trial on HME using the composition provided by client | 5-10 | 0.1 – 1 kg |
| 2 | Only Process development | Developing process on HME using the composition provided by client | 10 -20 | 2-3 kg |
| 3 | Troubleshooting | Trouble shooting for the process by providing HME process solution | NA | NA |
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