Product
Lactose Monohydrate
Lactose Monohydrate is a pharmaceutical filler for tablets and capsules, supplied in direct-compression grades to Ph. Eur./USP-NF.
- Grades / forms
- Direct compression
Overview
Lactose is a milk sugar refined to pharmaceutical purity. It is cheap, inert to most APIs, pleasant tasting and dissolves well, so it is one of the most common fillers in tablets and capsules. Milled grades are used in wet granulation; spray-dried and granulated grades flow and compress well enough for direct compression.
Because it is a reducing sugar, lactose can react with APIs that contain primary amines (the Maillard reaction), causing discolouration. Formulators screen for that interaction early. Specialist inhalation grades are used as carriers in dry powder inhalers.
Applications
- 1Direct compression tablets (spray-dried grades)
- 2Wet granulation filler (milled grades)
- 3Capsule filling
- 4Sachets and dry syrups
- 5Carrier in dry powder inhalers (inhalation grades)
Packing & storage
Packing
- 25 kg multi-wall paper bags with PE liner
Storage & handling
Store in closed containers in a cool, dry place away from strong odours.
Enquire
Get a price for Lactose Monohydrate
Send grade, quantity and destination port. Price, lead time and documents come back within one business day.
Request a quotation or call +91 97979 77958- Certificate of Analysis with every batch
- SDS in destination format
- Made to your specification
- Private label packing
Questions
Lactose Monohydrate, answered.
The Maillard reaction is a browning reaction between lactose, a reducing sugar, and APIs containing primary amine groups. It can discolour tablets and degrade the API, so compatibility is checked early in development.
Spray-dried and granulated lactose monohydrate grades are used for direct compression because they flow well and form strong tablets. Milled grades are better suited to wet granulation.
The amount of lactose in a typical tablet is small and is generally tolerated by most lactose-intolerant patients, but product labelling should declare it as required by local regulations.
Yes. Cosmo Chemistry manufactures and exports Lactose Monohydrate from Surat, Gujarat, India to more than 55 countries, for customers in the pharma industry. Send your grade, quantity and destination port for a quotation within one business day.
Every shipment of Lactose Monohydrate from Cosmo Chemistry includes a batch-specific Certificate of Analysis (COA) and Safety Data Sheet (SDS). Certificate of Origin, third-party pre-shipment inspection and destination-specific regulatory documentation are arranged on request.
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