Better Capacity Utilization through free-flowing granules for Direct compression at lesser tablet weight
Tailored solution to overcome challenges associated with Metformin formulation;
High volume and low value product.
BCS class I drugs – High solubility leads to higher weight in modified release tablet
Lump formation in API
Lengthy production time
Multiple analysis of RM and in-process
Product
% Drug conc.
API Pharmacopoeia
Lubricated / Non lubricated
Label claim
Tablet weight
Metformin HCl SR Granules
71.43%
IP
Lubricated
Each 700 / 1400 mg of lubricated granules contains Metformin 500 / 1000 mg
700 mg / 1400 mg
73.53%
IP
Lubricated
Each 680 / 1360 mg of lubricated granules contains Metformin 500 / 1000 mg
680 mg / 1360 mg
74.62%
IP/USP
Lubricated
Each 670 / 1340 mg of lubricated granules contains Metformin 500 / 1000 mg
670 mg / 1340 mg
77.52%
IP
Lubricated
Each 645 / 1290 mg of lubricated granules contains Metformin 500 / 1000 mg
645 mg / 1290 mg
Specification
Details
PSD
90% of particles are less than 850 micron (ASTM 20 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)
Pharmaceutical Granules, also referred to as Pharmaceutical Formulation Intermediates (PFIs), are multiparticulate systems in which APIs are combined with excipients to create ready-to-use formulation intermediates for oral solid dosage (OSD) form manufacturing.
Granules (PFIs) are designed to improve processing efficiency and dosage accuracy in various oral solid dosage forms such as tablets and capsules.
Granumet SR is a sustained-release Pharmaceutical Formulation Intermediate (PFI) containing Metformin as the active pharmaceutical ingredient (API).
Granumet SR granules are specifically developed to enable sustained release of Metformin, addressing the high-dose requirement and gastrointestinal (GI) tolerability challenges commonly associated with conventional Metformin formulations.
Metformin API powder is difficult to process due to poor flowability, high dose bulk, and rapid drug release, which can increase the risk of gastrointestinal side effects and variability and inconsistency in formulation.
Metformin sustained-release granules (Granumet SR) offers improved handling and content uniformity while enabling sustained release of Metformin through excipients, making it more suitable for consistent, scalable manufacturing of controlled and sustained-release oral solid dosage forms (OSDs).
Granumet SR (Metformin Granules) is primarily used in the development of sustained-release tablets for the management of diabetes mellitus.
The multiparticulate nature of Metformin granules provides formulation flexibility, allowing customization of dose strength and sustained-release profiles to meet therapeutic requirements.
This reduces dosing frequency, minimizes peak-related side effects, and enhances patient adherence, which is critical for long-term diabetes management.
Gangwal Healthcare ensures the quality of Granumet SR (Metformin Granules) through controlled and sustained-release granulation processes and stringent quality checks to maintain consistent drug content and drug release performance.
Granumet SR is available in multiple grades with defined Metformin HCl strengths, such as 500 mg sustained-release granules designed for 645 mg, 670 mg, and 700 mg tablet weights, enabling formulators to select the appropriate grade based on dosage strength and formulation requirements while meeting regulatory standards.
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