Will anhydrous beta lactose take up moisture and become alpha lactose monohydrate in the presence of high humidity?
Not under the high humidity conditions found in accelerated storage. Interconversion of alpha and beta lactose can only take place in solution, and at 75% relative humidity, anhydrous lactose only takes up about 0.5% by weight of water.
Which material is best suited for a dry granulation process?
We would only recommend anhydrous grades of lactose (key range SuperTab
® 21AN and Lactopress
® Anhydrous 250) for dry granulation. Anhydrous lactose does not lose compactability in dry granulation processes.
What is the difference between milled and sieved lactose and direct compression lactose?
Milled lactose and sieved lactose are grades of alpha-lactose monohydrate that are processed to give a particular particle size distribution. Sieved grades are coarser than milled grades. In general milled lactose is primarily used for wet granulation applications where its fine particle size helps to confer good tablet hardness, but it does no flow well.
Sieved lactose flows well but it does not compact well on its own. It may be used in some direct compression tablet applications, but it should be combined with an excipient with good compaction properties, such as Pharmacel® (microcrystalline cellulose).
Direct Compression lactose is processed especially to have both good flow and good compaction properties, the two key properties for a direct compression excipient.
What are recommended storage conditions?
It is recommended to store the product in the original and closed packaging protected form solvents and under normal warehouse conditions between temperatures of 5 and 25 degrees Celcius and relative humidity of max. 70%.
Can medicines containing lactose be taken by lactose intolerant persons?
Yes. Lactose intolerance (the symptoms of intestinal discomfort) are caused by high quantities of lactose.
For example:
“In patients with mild tolerance, up to 15 g of lactose can be taken within a short time without symptoms.”
Gordon A. Greenberg: Modern Nutrition in Health and Disease, Maurice E. Shils, Vernon R. Young, Lea & Febiger, Philadelphia, 1988
“… lactose malabsorbing subjects can tolerate amounts of lactose up to 11 g, if lactose is combined with a meal. It is likely that even higher amounts are tolerated when distributed across meals over the day...”
G. Schaafsma and G. van Poppel in Lactose intolerance: nutritional implications, TNO-report V96.948
“… the amount of ingested lactose required to produce symptoms varies but is reported to be about 12 to 18 g…”
DL Swagerty Jr., M.D., M.P.H., AD. Walling, M.D., and RM Klein, Ph.D. American Family Physician, Vol 65 No. 9, May 1st 2002,
The quantity of lactose in a typical tablet varies but 200mg may be taken as typical. Thus 50 or more such tablets would be required to provoke lactose intolerance.
May lactose used in medicine cause allergy?
Lactose is highly purified and the allergenic components (proteins) in cow’s milk are removed or denatured during processing.
A number of studies have demonstrated the non-allergenicity of lactose:
“Even children hypersensitive to CM (cow’s milk) are clinically tolerant to lactose and can safely consume foods and drugs with lactose from bovine sources as an ingredient.” A. Fiocchi, …, Clinical tolerance to lactose in children with cow's milk allergy. Pediatrics. 2003 Aug;112(2):359-62.
Even in asthmatic patients, lactose did not provoke an allergic response when inhaled. “.. this study showed that high concentrations of lactose were not associated with any clinically important changes in FEV1 or airway conductance in asthmatic patients. No statistically significant difference from placebo was observed.” P. Thoren,.. The effect of different concentrations of lactose powder on the airway function of adult asthmatics, Respiratory medicine, 2001, 95, 870 – 875.