11) Incompatibilities: A Maillard-type condensation reaction is likely to occur between lactose and compounds with a primary amine group to form brown, or yellow-brown-colored products. Lactose is also incompatible with amino acids, aminophylline, amphetamines, and lisinopril. 12) Safety: Adverse reactions to lactose are largely attributed to lactose intolerance, which occurs in individuals with a deficiency of the intestinal enzyme lactase. 13) Regulatory Status: Included in the FDA Inactive Ingredients Guide (IM, IV, and SC injections; oral capsules and tablets; inhalation preparations; rectal, transdermal, and vaginal preparations). Include in nonparenteral and parenteral medicines licensed in the UK. Include in the Canadian List of Acceptable …show more content…
7) Empirical Formula Figure 17: Chemical Structure of Mannitol 8) Applications in Pharmaceutical Formulation or Technology Mannitol is widely used in pharmaceutical formulations and food products. In pharmaceutical preparations it is primarily used as a diluent (10–90% w/w) in tablet formulations, where it is of particular value since it is not hygroscopic and may thus be used with moisture-sensitive active ingredients. Mannitol may be used in direct-compression tablet applications, for which the granular and spray-dried forms are available, or in wet granulations. Granulations containing mannitol have the advantage of being dried easily. Specific tablet applications include antacid preparations, glyceryl trinitrate tablets, and vitamin preparations. Mannitol is commonly used as an excipient in the manufacture of chewable tablet formulations because of its negative heat of solution, sweetness, and ‘mouth feel’. 4.2.4 Hypromellose / Hydroxypropyl methylcellulose52,67 1) Nonproprietary Names BP: Hypromellose JP: