Lactitol monohydrate (D-Lactitol monohydrate)

Structure of lactitol (4-O-beta-D-galactopyranosyl-D-glucitol) monohydrate: and artificial sweetener

C12H24O11.H2O, Mr = 362.4, orthorhombic, P2(1)2(1)2(1), a = 7.808 (2), b = 12.685 (2), c = 15.931 (3) A, V = 1577.9 (6) A3, Z = 4, Dx = 1.525 Mg m-3, lambda(Mo K alpha) = 0.71073 A, mu = 0.13 mm-1, F(000) = 776, T = 295 K, R = 0.031 for 1781 unique reflections with I greater than 2.5 omega (I). The galactopyranosyl ring has the 4C1 chair conformation and the conformation of the bent glucitol C-atom chain is MAA. The torsion angles characterizing the conformation of the glycosidic linkage are -86.3 (2) degrees [O(5)--C(1)--O(1)--C(14)] and 116.8 (2) degrees [C(1)--O(1)--C(14)--C(13)]. All hydroxyl groups act as donors in hydrogen bonds; three bonds are intramolecular. With the exception of O(1) of the glycosidic link which is not an acceptor and O(6) of the glucitol residue which is a double acceptor, all O atoms accept one hydrogen bond. The water molecule donates two and accepts one hydrogen bond.

Energy balances of eight volunteers fed on diets supplemented with either lactitol or saccharose

1. Complete 24 h energy and nitrogen balances were measured for eight subjects both while consuming a basal diet supplemented with 49 g saccharose/d (diet S) and while consuming the same basal diet but supplemented with 50 g lactitol monohydrate/d (diet L). 2. The subjects ate the two diets for 8 d. Faeces and urine were collected for the final 4 d. Exchange of respiratory gases (oxygen, carbon dioxide, hydrogen and methane) was measured during the final 72 h while the subjects stayed in an open-circuit respiration chamber, 11 m3, and simulated office work. Before eating diet L, subjects ate 50 g lactitol daily for 10 d. 3. On diets L and S, faecal moisture content averaged 0.787 and 0.753 g/g respectively, the difference being significant (P less than 0.05). On diet L, energy and nitrogen digestibilities and energy metabolizability averaged 0.922, 0.836 and 0.881 respectively, and on diet S 0.935, 0.869 and 0.896 respectively; the differences were also significant (P less than 0.05). Urinary energy losses and N balances were not significantly different for the two diets. 4. In all subjects only traces of methane were produced but hydrogen production differed significantly (P less than 0.05) for diets L and S, being 2.3 and 0.4 litres (normal temperature and pressure)/d respectively. 5. Intakes of metabolizable energy (ME) were corrected, within subjects, to energy equilibrium and equal metabolic body-weight. The corrected ME intakes did not show differences between diets. However, when on diet L the subjects were probably less active than when on diet S because differences within subjects of ankle actometer counts between diets showed a high correlation with the corresponding differences in corrected ME intakes (r 0.92). Further correction of ME intake toward equal actometer activity showed a significant (P less than 0.05) difference between diets: for maintaining energy equilibrium 5.6 (SE 0.8; P less than 0.05)% more ME from diet L was needed than from diet S. The reliability of this 5.6% difference depends on whether or not one ankle actometer gives an accurate picture of the subject's physical activity. 6. The energy contribution to the body is clearly smaller from lactitol than from saccharose, certainly due to the effect of lactitol on digestion, and probably also due to the effect on the utilization of ME.

Effects of Diluents on Physical and Chemical Stability of Phenytoin and Phenytoin Sodium

The focus of the present work was to investigate compatibility between commonly used diluents and the drug (salt and acid form of the phenytoin). Lactose monohydrate (LMH), lactitol hydrate (LCT), and mannitol (MNT) were selected based on commercial products information of phenytoin sodium (PS) and phenytoin acid (PHT). Binary mixtures of the drug-diluent were stored at 60°C and 40°C/75% RH. Similarly, two commercial products, namely Product-A and Product-B, were also investigated in in-use stability. Color of PS-LMH changed from white to yellowish-brown and pH dropped by 3.4 units after 4 weeks exposure. FTIR, XRPD, and NIR chemical images indicated disproportionation in PS-LMH and PS-LCT mixtures stored at 40°C/75% RH. Furthermore, PS-LMH also indicated chemical interactions as indicated by distortion of LMH peaks. PHT-diluent mixture did not exhibit any physical and chemical modifications. Product-A changed color, increased weight, dropped pH value, and exhibited disproportionation and chemical reactions. The dissolution of Product-A decreased from 83.3 ± 1.4 to 7.1 ± 4.4% on 8 weeks exposure to 30°C/75% RH. On the other hand, Product-B did not change; however, dissolution decreased by 15%. In conclusion, PS showed disproportionation and chemical reactions with LMH. Therefore, LMH should be avoided in PS formulations.