Optimisation of the Manufacturing Process of Organic-Solvent-Free Omeprazole Enteric Pellets for the Paediatric Population: Full Factorial Design.

Liquid formulations are mostly used in the paediatric population. However, with certain active pharmaceutical ingredients (APIs), it is very difficult to guarantee quality and stability; this is the case, for example, with omeprazole. Omeprazole is used as a model drug due to the lack of a paediatric formulation meeting gastro-resistance requirements, which remains a challenge today. In this experimental study, the development of enteric polymer-coated pellets is proposed. It is proposed to use aqueous coating dispersions without the use of organic solvents, which are commonly used in fluidised bed coatings. To do this, the design of experiments method is used as a statistical tool for experiment creation and the subsequent analysis of the responses. In particular, this study uses a randomised full factorial design. The mean weight increases of the protective layer and the enteric coating are chosen as factors. Each factor is assigned two levels. Therefore, the design of the used experiments is a 22 + 1 central point. Overall, the obtained pellets can be an alternative to the compounding formulas of omeprazole that are currently used in the paediatric population, which do not meet the gastro-resistance specifications necessary to guarantee the therapeutic efficacy of this active ingredient.

Reactive balance responses to a trip and slip during gait in people with multiple sclerosis.

BACKGROUND: To examine reactive balance responses to a trip and slip during gait in people with multiple sclerosis (MS). METHODS: This cross-sectional laboratory study involved 29 participants with MS (50.6 ± 13.4 years) and 29 gender-and-aged-matched healthy controls (50.9 ± 19.2 years). Falls following an induced trip and slip along a 10 m walkway, approach (e.g. gait speed, step length, foot contact angle) and recovery strategies (e.g. response time, extrapolated centre of mass position, margin of stability) were compared between the two groups. FINDINGS: The rate of falls was significantly higher in the participants with MS relative to healthy controls (rate ratio=2.82, 95% confidence interval [CI]=1.42, 5.61). Participants with MS also experienced more trip falls (odds ratio [OR]=3.90, 95% CI=1.16, 13.08) and more slip falls (OR=6.27, 95% CI=1.95, 20.22) than the heathy controls. Participants with MS had significantly slower gait speed, step length, cadence, and foot contact angle during approach (P < 0.05). Following slips, participants with MS had significantly greater stance limb knee flexion (P < 0.05), suggesting inadequate lower limb support to recover balance post-slip. Following trips, participants with MS had significantly delayed response initiation, lower toe clearance, shorter step length, and greater trunk sway (P < 0.05). Fewer participants with MS showed a hopping response to clear the obstacle (P < 0.05). INTERPRETATION: Multiple sclerosis impairs reactive balance responses to a trip and slip associated with reduced lower limb function and delayed postural responses. Neurorehabilitation targeting reactive balance may facilitate fall prevention in people with multiple sclerosis.