Optimized Solid Dispersion with enhanced solubility
Tailored solution to offer advantage over below;
High volume
BCS Class II drug
Moisture and light sensitivity
Process Complexities (multi-step)
Lengthy production time
Multiple analysis of RM and in-process
Product
% Drug conc.
API Pharmacopoeia
Lubricated / Non lubricated
Label claim
Tablet weight
Telmisartan Granules
28.88%
IP/USP
Non-Lubricated
Each 138.50 mg of Non-Lubricated granules contains Telmisartan 40 mg
Any weight higher than 138.50 mg by adding one or more extra-granular excipients like filler, disintegrants, binder, lubricant
19.05%
IP
Lubricated
Each 210.00 mg of Lubricated granules contains Telmisartan 40 mg
210.00 mg
16.67%
EP
Non-Lubricated
Each 208.33 mg of Non-Lubricated granules contains Amlodipine besylate equivalent to Amlodipine 5 mg
240 mg
Specification
Details
PSD
90% of particles are less than 250 micron (ASTM 60 passed)(PSD can be customized based on customer requirements)
Pharmacopoeia
IH Specification
Shelf life
2 years re-test
Pack size (MOQ)
5 kg, 10 kg, 20 kg
Batch size
Up to 500 kgs
Lead time
45 to 60 days (will be confirmed at the time of purchase order)
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