Development and optimization of taste-masked orally disintegrating tablets (ODTs) of clindamycin hydrochloride

The purpose of this research was to develop an orally disintegrating tablet (ODT) dosage form containing taste-masked beads of clindamycin HCl. Several formulation strategies were evaluated and a taste-masked ODT of clindamycin HCl was prepared without the use of a waxy cushioning agent. Clindamycin HCl (ca. 46% w/w) was coated onto microcrystalline cellulose beads (Cellets® 200) followed by the addition of a taste-masking layer of amino methacrylate copolymer, NF (Eudragit EPO® (EPO)) coating suspension. The efficiency of both the drug coating process and the taste-masking polymer coating process, as well as the taste masking ODTs was determined using potency and drug release analysis. Magnesium stearate was found to be advantageous over talc in improving the efficiency of the EPO coating suspension. A response surface methodology using a Box–Behnken design for the tablets revealed compression force and levels of both disintegrant and talc to be the main factors influencing the ODT properties. Blending of talc to the EPO-coated beads was found to be the most critical factor in ensuring that ODTs disintegrate within 30?s. The optimized ODTs formulation also showed negligible (<0.5%) drug release in 1?min using phosphate buffer, pH 6.8 (which is analogous to the residence time and pH in the oral cavity). By carefully adjusting the levels of coating polymers, the amounts of disintegrant and talc, as well as the compression force, robust ODTs can be obtained to improve pediatric and geriatric patient compliance for clindamycin oral dosage forms.     

Supplementation of lysolecithin in milk replacer for Holstein dairy calves: Effects on growth performance,health, and metabolites

Lysolecithin is an antiinflammatory emulsifier associated with improved apparent digestibility of total dietary fat and improved feed efficiency in dairy cattle. However, it is unknown if lysolecithin (LYSO) improves performance in calves. Moreover, since many conventional milk replacers use vegetable-sourced fat (e.g., palm oil), nutrient absorption and fecal score may be affected in neonatal calves. Thus, the objective of this study was to evaluate the effects of LYSO supplemented in milk replacer on performance, metabolites, and gut health of preweaned dairy calves. Holstein calves (n = 32) with adequate passive transfer were assigned in pairs (16 blocks) balanced by birth weight, date of birth, and sex at 1 d of age to randomly receive either LYSO (mixed in 2 milk replacer feedings at a rate of 4 g/d Lysoforte, Kemin Industries Inc., Des Moines, IA) or a milk replacer control (nothing added). Both treatments were fed 6 L/d milk replacer [22.5% crude protein, 16.2% crude fat (vegetable oil fat source) on a dry matter basis with 14% solids] by bucket in 2 daily feedings for 56 d. Calves were individually housed in wooden hutches and offered a commercial calf starter (24.6% crude protein and 13.9% neutral detergent fiber) and water by bucket ad libitum. Feed refusals and calf health was assessed daily. Weights and blood metabolites (glucose, total serum protein, albumin, creatinine, triglycerides, and cholesterol) were sampled weekly, and calves completed the study before weaning at 56 d of age. The effects of LYSO on calf average daily gain, feed efficiency, and blood metabolites were evaluated using a linear mixed model with time as a repeated measure, calf as the subject, and block as a random effect in SAS (SAS Institute Inc., Cary, NC). The effect of LYSO to improve the odds of abnormal fecal score was evaluated using a logistic model. Supplementation of LYSO increased average daily gain (control 0.28 ± 0.03 kg; LYSO 0.37 ± 0.03 kg; least squares means ± standard error of the mean) and increased feed efficiency (gain-to-feed; control 0.25 ± 0.03; LYSO 0.32 ± 0.03). Similarly, LYSO calves had a higher final body weight at d 56 (control 52.11 ± 2.33 kg; LYSO 56.73 ± 2.33 kg). Interestingly, total dry matter intake was not associated with LYSO despite improved average daily gain (total dry matter intake control 1,088.7 ± 27.62 g; total dry matter intake LYSO 1,124.8 ± 27.62 g). Blood glucose, albumin, creatinine, triglycerides, and cholesterol were not associated with LYSO. Indeed, only total serum protein had a significant interaction with LYSO and age at wk 5 and 6. Moreover, control calves had a 13.57 (95% confidence interval: 9.25–19.90) times greater odds of having an abnormal fecal score on any given day during the diarrhea risk period from d 1 to 28. The inclusion of LYSO as an additive in milk replacer in a dose of 4 g/d may improve performance, and calf fecal score, preweaning. Further research should investigate the mechanisms behind the effects of LYSO on fat digestibility in calves fed 6 L/d of milk replacer with vegetable-sourced fat.