Lactose manufacture

In the case of lactose manufacture, crystals of uniform size are produced by first grinding part of a previous batch and taking a quantity with the required nunriiber of particles, then introducing these as seed crystals into a solution that is gradually cooled with gentle stirring. Variation in size of the seed ciystals does not affec t me size of the produc t ciystals. 

Brinkman, G. E. 1976. New ideas for the utilization of lactose—principles of lactose manufacture. J. Soc. Dairy Technol. 29 101-107. 

Rajah KK, Blenford DE, eds. The ALM Guide to Lactose Properties and Uses. The Hague The Association of Lactose Manufacturers, 1998. 

C (rapid heating). Manufactured by the oxidation of lactose or the galactans from wood with nitric acid. When heated with water it forms a soluble lactone. Converted to furoic... 

Potassium chlorate is used mainly in the manufacture of matches (qv) and pharmaceutical preparation. In pyrotechnics, chlorate salts may be mixed with certain organic compounds such as lactose to give a relatively cool flame, so that certain dyes may be incorporated in the mixture to give colored flares. 

Proposed IDE standards for caseiaate are hsted ia Table 4. la most cases the sodium salt is preferred for emulsificatioa the calcium salt is preferred for imitation cheese. Caseia and caseiaates must be stored carefliUy and evaluated for flavor before use ia products. Improperly manufactured or stored caseia—caseiaate has a very stroag, musty off-flavor. Excessive fat coateat, high lactose and moisture contents, and high storage temperatures contribute to undesirable flavor development. 

Whey is the fluid obtained by separatiag the coagulum from cream and/or skim milk, and is a by-product of either caseia or cheese manufacture. The composition of whey is determined by the method of curd formation, curd handling practices, and methods of handling whey as it is separated from the curd. Dried acid whey contains ca 12.5 wt % proteia (total nitrogea x6.38), 11.0 wt % ash, and 59 wt % lactose, whereas sweet whey contains 13.5 wt % proteia, 1.2 wt % fat, 8.4 wt % ash and 74 wt % lactose. The composition varies with the type of acid used (7). 

Lactose, the milk sugar, is a reducing disaccharide consisting of glucose and galactose moieties. The estimated annual worldwide availability of lactose as a byproduct from cheese manufacture is several million tons [1,2], but only about 400 000 t/a lactose is processed further from cheese whey [3], Non-processed whey is an environmental problem due to its high biochemical and chemical oxygen demand [2], The use of lactose as such is limited by two main factors relatively low solubility of lactose in most solvents and lactose intolerance in human body [1]. 

Many surface area studies have investigated various properties of excipients. The relationship between excipient grades, flow properties, particle sizes, and surface areas have been studied. Fast-flo lactose is manufactured to contain larger particles (approximately 50 jim) than hydrous lactose (approximately 20 /zm) [23], This has been done to improve the flow properties of the fast-flo... 

In 1968, fifty-one patients suffered from an epidemic of anticonvulsant intoxication in Brisbane. A thorough investigation revealed that the intoxication was caused by altering one of the excipients from calcium phosphate to lactose in the drug product Phenytoin Capsule without adequate pre-testing by the manufacturer. 

Presented together by the British, European, Japanese, and U S. Pharmacopeias, the first Interpharmacopeial Open Conference on Standards for Excipients was convened in Orlando, FL, from January 30-February 1, 1991 (Table 1). Attended by 165 participants, representation included 11 countries, 59 pharmaceutical or excipient manufacturers or suppliers, three regulatory agencies (FDA, EEC, and HPB), and seven pharmacopeias (the presenters and the French, Italian, and Spanish Pharmacopeias) [17]. In preparation for this conference, USP convened open meetings on Magnesium Stearate and Lactose attended by almost every major manufacturer from Europe and the United States. 

By pre-treating milk with lactase, all adults can enjoy milk and a whole range of other lactose-free dairy products can be made such as ice cream and yogurt. In the production of ice cream, lactose hydrolysis can also be used to improve certain properties such as the texture, sweetness and tendency to crystallize. The increased sweetness is also advantageous in the manufacture of flavored milk products because less sugar needs to be added. 

For the pharmaceutical product development scientist, there is clearly a need for objective information about the practical performance of different excipients and their various grades. In this chapter we set out to bring together the results of some of our ongoing evaluations of the physical and mechanical properties of excipients commonly used for the manufacture of solid oral dosage forms. In this particular article, we have chosen to focus on the fillers that are most commonly used in the manufacture of immediate release tablets microcrystalline cellulose (MCC), lactose, calcium phosphate, and mannitol (1). 

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