Internal Lubricant Content in inhalation Capsules

Autores UPV
Año
CONGRESO Internal Lubricant Content in inhalation Capsules

Abstract

Pulmonary delivery is being investigated as a route for delivering active pharmaceutical ingredients that cannot be administered through the standard oral route, as well as offering an improved alternative to the parenteral route. The use of hard capsules in dry powder inhalers (DPIs) to deliver formula- tions to the lung has been in use since 1970, and recently there has been an interest in returning from metered-dose systems to capsule-based systems be- cause they are simple to formulate, cheap to manufacture, and patient-friendly. The original inhalation grade hard capsules were made from gelatin, which be- comes brittle when exposed to low humidities. Inhalation grade hypromellose (HPMC, carragean gelling agent) has been developed in the last few years to over come this problem and has also been shown to have better aerosolization properties. Hard capsules are made by a dipping process in which surface lubricant is an essential processing aid for removing dried capsule shells from the manu- facturing pins. This lubricant has been shown to have an effect on powder retention in capsules that are used for inhalation of medicines . The response variable is the internal lubricant content (ILC). The capsule manufacturing process depends on many factors. Three of them were cho- sen by experts in order to evaluate their influence on ILC: pin location, the pump flow and the time. An ANCOVA model was used. Our experimental desing have two categorical factors (location and pump flow) and a numerical covariable (time). This study was presented at the meeting Respiratory Drug Delivery 2015 (Nice). In this paper we study two new points. First, the main interest is to know the time interval where the ILC is between the tolerance limits. A local re- gression approach will be used to construct local confidence regions to the response. In such way, we can estimate more properly the lower and upper limits. Secondly, the response is a temporal function giving as the observation of ILC. These functions depends on the two categorical experimental factors. A functional analysis of variances will be performed in order to evaluate each experimental factor.