Utilization of Starch Micro-Spheres as a Core Material for Dry Powder Layering of an API to Facilitate High API

API layering onto multi-particulate core materials has become an increasingly popular method of drug delivery in the pharmaceutical industry in recent years. The ability to control dosing, customize the dosing rate and reduce the risk of dose dumping along with the ability to create orally disintegrating tablets (ODT’s) with controlled release particles are all advantages to multi-particulate dosage forms.

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Utilization of Starch Micro-Spheres as a Core Material for Dry Powder Layering of an API to Facilitate High API Loading in Particles Below 250 Microns

A starch microsphere was used as a core material in a dry powder layering process where an 80% Active Pharmaceutical Ingredient (API) content was required in a particle with a finished size below 250 microns. Size, shape, efficiency, process and content analysis of the finished coated particles showed that the starch microspheres were successfully used as a core material to create high API loaded particles under 250 microns in size.

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Controlled Release Coatings of Ethylcellulose on Drug Loaded Multiparticulates Comparison of Rotor Dry Layering with Wurster Bottom Spray Process

Spray coatings of ethylcellulose for controlled release on multi-particulate dosage forms are common in the pharmaceutical industry, but can be disadvantageous because of long process times, need for organic solvent capabilities, and particulate agglomeration. This study highlights the advantages of a rotor dry powder layering process in overcoming these deficiencies by comparing performance, productivity and cost to solvent based Wurster coating and aqueous-based Wurster coating.

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Effect of Particle Size and Shape on the Coating Level Required for Taste Masking Multi-Particulates Utilizing Dry Powder Layering

Taste masking of multi-particulate dosage forms has become widespread in the pharmaceutical industry, particularly with small particles used in ODT applications. The amount of coating required to fully mask the API can be variable as the size and shape of the substrate changes. This study attempts to quantify the effect of size and shape on the coating
requirements to fully taste mask multi-particulates.

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Novel Method for Introducing Dry Powder Directly into the Spray Zone of a Bottom Spray Wurster Coating Process

Wurster coating of multi-particulates with polymer suspensions and solutions is widespread in the pharmaceutical industry. Several formulations for polymer coatings of aqueous dispersions and organic solvent based polymer systems require glidants such as talc to be suspended into the polymer solutions to cut down on polymer tackiness and reduce agglomeration. These glidants can fall out of solution during the process, causing gun plugging, line plugging, extended processing times and inefficient coating. This study focuses on a modification to an existing Wurster spray system to add solid glidants via a powder feeder in dry form during the Wurster coating process.

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A Comparison of Content Uniformity and Dissolution of API Applied to Different Spherical Core Materials using a Controlled Release Drug Layering Process

To investigate the process of dry powder drug layering and enteric coating on three spherical core materials: two traditional cores, sugar/starch and microcrystalline cellulose, and a newer type of core manufactured from starch and maltodextrin. To compare dissolution and content uniformity for the Active Pharmaceutical Ingredient (API) applied at different percentages on powder layered cores and enteric coated finished spheres.

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Novel Rotary Granulation Process (SFC) as an Alternative to Top Spray Granulation

Rotary granulation has been viewed as a favorable granulation method in the industry due to the uniformity and round shape of the granulations produced. It has failed to gain wide use as a production method due to small batch sizes and limited drying capabilities that can lead to long processing times. A novel screened rotary fluid bed insert with dual airflows combines the large batch size and drying capacity of the top spray fluid bed process with the size and shape uniformity of the traditional rotor process.

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Effect of Different Solubilizers on Poorly Soluble Drug in DC Formulation Using High Shear Granulator

The objective of this study was a comparative investigation of release profiles of a poorly soluble model drug, carbamazepine, by the dry granulation method using Poloxamers as the solubilizing agents. The solubilizing capacity of Poloxamers 237 and 338 (Kolliphor™ P 237 and P 338, respectively) were compared to Poloxamer 188 and 407 (Kolliphor™ P 188 and P 407 respectively) in dry granulation using High Shear Granulator. The study involved carbamazepine as a model poorly – water soluble drug, and the mixture of various excipients’ particles using a high shear mixer granulator. The robustness of this dry granulation method in DC formulation is measured by the release profile of the drug solubilized by each of the Poloxamers.

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Effect of Mixing Time on the Solubilization Of Poorly, Water Soluble Drug in DC Formulation, Using Soluplus® in High Shear Granulator

This investigation analyzed the solubilization capacity of Soluplus® in dry granulation. Soluplus® is a novel, graft copolymer of polyvinyl caprolactam – polyvinyl acetate – polyethylene glycol. Carbamazepine was used as a model drug, and the homogeneity of the mixture of various excipients’ particles in the high shear mixing bowl was determined. The robustness of dry granulation method in DC formulation was measured by the content uniformity of the mixture at a given length of mixing time and quantified by the percent of drug released at different sample points and levels (top and bottom).

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