Pharmaceutical lactose is a clear, colorless, inert, and highly-pure form of lactose which is used in the pharmaceutical industry. Lactose is a naturally-occurring compound in the milk of mammals in the form of simple sugar or carbohydrates, also called as milk sugar. Pharmaceutical lactose is derived during the whey concentration process of bovine milk. Pharmaceutical lactose depending on the temperature used during production, could be either monohydrate crystalline or anhydrous crystalline. Pharmaceutical lactose has been used widely as an excipient in the formulation of tablets and capsules in the pharmaceutical industry since the 1900s. Pharmaceutical lactose can be used for both dry and wet granulation processes. Most widely-used pharmaceutical lactose in the pharmaceutical formulation is crystalline α-lactose monohydrate.
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Pharmaceutical Lactose Market: GRAS Status and the Acceptance from Government Bodies
The demand for pharmaceutical lactose is driven mainly by the growing pharmaceutical industry. With an increase in population and usage of pharmaceuticals in developing economies, the pharmaceutical industry is growing at a rapid rate. With an increase in the pharmaceutical industry, pharmaceutical ingredients are in high demand.
The approval from several government organizations for the use of pharmaceutical lactose in the formulation of capsules, tablets, dry powders, and inhalers due to the chemical and physical stability of the lactose is another main driver for the market. Pharmaceutical lactose has GRAS status and is included in the FDA Inactive Ingredient Database. Moreover, pharmaceutical lactose is included in the non-parenteral and parenteral medicines licensed in the UK. Due to these acceptations from the FDA and the UK Government, the use of pharmaceutical lactose is likely to increase.
Pharmaceutical lactose is an all-natural product which has low hygroscopicity, water solubility, compatibility with active ingredients and other excipients, bland taste, as well as excellent physical and chemical stability. These properties of pharmaceutical lactose make it an excellent choice for the pharmaceutical manufacturer.
The use of pharmaceutical lactose in the pharmaceuticals is mainly restrained due to the origin of the product when considering the vegan customers, as the product is mainly derived from bovine milk. The market for pharmaceutical lactose is threatened by other available excipients that are made from plant-based ingredients. Most common pharmaceutical excipients are starch, cellulose, and alginates.
Pharmaceutical Lactose Market: Segmentation
Pharmaceutical lactose market segmentation by product type:
- Crystalline Monohydrate Lactose
- Inhalation Lactose
- Granulated Lactose
- Spray-dried Lactose
Pharmaceutical lactose market segmentation by application:
- Carriers
- Binders
- Diluents
- Filling Agents
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Global Pharmaceutical Lactose Market: Key players
Merck KGaA, Meggle AG, Kerry Inc., Amor Pharma, BASF SE, DFE Pharma, Davisco Foods International, The Lactose Company of New Zealand Limited, AIP Pharmaceuticals, Norvatis AG, Bayer AG, ALPAVIT, Abbott Laboratories, etc. are some of the key players in the global pharmaceutical lactose market