Lactose monohydrate, identified by the CAS number 10039 - 26 - 6, is a naturally occurring disaccharide sugar derived from milk. It consists of one galactose and one glucose unit joined by a β - 1,4 - glycosidic bond. The monohydrate form means that each lactose molecule is associated with one water molecule.
It appears as a white, crystalline powder with a mild, sweet taste. The molecular formula of lactose monohydrate is C12H22O11·H2O, and its molecular weight is approximately 360.31 g/mol. It has a melting point in the range of 201 - 202 °C (anhydrous form) and is soluble in water, but insoluble in ethanol and ether.
In the pharmaceutical industry, lactose monohydrate is widely used as an excipient. It serves as a filler or diluent in tablets and capsules, providing bulk to the formulation and facilitating the manufacturing process. Due to its excellent compressibility and compatibility with active pharmaceutical ingredients (APIs), it helps in the production of high - quality solid dosage forms.
In the food industry, it is used as a sweetener, bulking agent, and stabilizer. It can enhance the flavor and texture of various food products such as baked goods, dairy products, and confectionery. Additionally, it can be used as a carrier for flavorings and other additives.
In the cosmetics industry, lactose monohydrate can be used in skin care products. Its mild nature makes it suitable for use in formulations targeting sensitive skin, and it may contribute to the moisturizing properties of creams and lotions.
Pharmaceutical Use: When used in tablet production, lactose monohydrate is usually mixed with the API and other excipients in a specific ratio. The mixture is then granulated if necessary and compressed into tablets. For capsule filling, it can be directly mixed with the API and filled into the capsules. The amount used depends on the dosage strength and the formulation requirements of the specific drug product.
Food Use: In baking, it can be added to the flour mixture. The amount can vary according to the recipe, but typically, it can replace a portion of the regular sugar to adjust the sweetness and texture. In dairy products, it can be added during the processing stage to improve the mouthfeel and stability.
Cosmetic Use: In skin care formulations, it is usually dissolved in the aqueous phase of the product. The concentration can range from a few percent to higher levels depending on the desired properties of the final product.
Pharmaceutical Case: A pharmaceutical company was developing a new tablet formulation for a pain - relief drug. They used lactose monohydrate as the main filler. By carefully selecting the grade of lactose monohydrate and optimizing the mixing and compression parameters, they were able to produce tablets with uniform hardness, good disintegration time, and accurate drug release profiles. This led to a successful product launch in the market with high patient acceptance.
Food Case: A bakery was looking to improve the texture and shelf - life of their bread. They incorporated lactose monohydrate into the bread recipe. The lactose monohydrate helped in retaining moisture, resulting in softer and fresher - tasting bread for a longer period. Customers noticed the improvement in quality, and the bakery saw an increase in sales.
Cosmetic Case: A cosmetic brand was developing a moisturizing cream for sensitive skin. They added lactose monohydrate to the formulation. The lactose monohydrate provided a gentle and moisturizing effect without causing any irritation. The product received positive feedback from customers with sensitive skin, enhancing the brand's reputation in the market.
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