Scientific Presentations

OUR SCIENTIFIC POSTERS AND RAPID FIRE PRESENTATIONS AT AAPS PHARMSCI360 2023

Fill out the form below to get access to all our four posters and two rapid fire presentations. You will receive them in an email right after the event!

• Characterization of Compression Behavior of Co-processed Excipient for Production of Orally Dispersible Tablets and of Their Blends with Active Ingredient

Monday, October 23, 2023 | 9:30 AM – 10:30 AM ET

Abstract / Poster Number: M0930-11-71

• A DoE Approach to Study the Influence of TSWG Process Parameters on the Characteristics of Granules and Tablets 

Monday, October 23, 2023 | 11:30 AM – 12:30 PM ET

Abstract / Poster Number: M1130-11-70

• Impact of Tooling Size on the Heckel Profile and Derived Compressibility Parameters

Tuesday, October 24, 2023 | 9:30 AM – 10:30 AM ET

Abstract / Poster number: T0930-03-20

• A Study to Assess the Gastro-Resistance and Dissolution Rate of Enteric Coated Not-Banded Gelatin and HPMC Capsules  

Wednesday, October 25, 2023 | 9:30 AM – 10:30 AM ET

Abstract / Poster Number: W0930-11-76

Presented by: Piero Piccinni, Senior Supervisor • Drug Product Manufacturing Operations

RAPID FIRE PRESENTATIONS

How twin-screw wet granulation factors impact granules and tablets attributes Presentation date and time: Monday, October 23, 3:15-3:30pm Presented by: Piero Piccinni, Senior Supervisor • Drug Product Manufacturing Operation

Abstract - The twin-screw wet granulation (TSWG) is a manufacturing process showing versatility, straightforward scale-up and the possibility of integration in a continuous manufacturing line. The presentation will focus on a case-study in which, a leading formulation containing a soluble drug (namely niacin), was used in a 2(5-1) fractional factorial design of experiment (DoE). This screening study was conducted to assess the influence of five factors (screw design, screw speed, liquid/solid ratio, powder feed rate and milling screen type) on the process outcomes and the quality attributes of granules and tablets. All statistical models were significant with p < 0.05 and a high level of goodness of fit (R2) was observed for the majority of responses. The TSWG was a viable approach to manufacture granules with suitable friability and flowability. The selection of the milling sieve was critical for the attributes of the granules: the screen type influenced the granule PSD, friability and density also as an interaction with other factors thus, the importance of the granulation downstream. The tablets showed adequate tensile strength and friability. With low screw speed and high L/S ratio (as a main effects) harder tablets were obtained. Faster disintegration was achieved with a low-shear screw configuration and high L/S ratio. In conclusion, a screening design was implemented as a “model view” to evaluate the impact of key TSWG process parameters towards the properties of granules and tablets.

 

BATA to evaluate drug unpleasant taste and select masking strategy Presentation date and time: Wednesday, October 25, 3-4 pm Presented by: Claudio Marcello Marzo, Associate Scientist • In Vivo Safety

Abstract - The taste of an oral medication is a critical quality attribute for therapeutic adherence and patient compliance, especially in children. The brief-access taste assessment (BATA) is an in vivo screening tool with great promise in providing the assessment of APIs aversiveness that may predict human taste responses. The BATA assay operationally defines aversive taste as suppression of the rate at which a rodent licks from sipper tubes that deliver tasting solutions or suspensions.   To validate a BATA model in our facility, independent groups of naïve male rats were given access to different compounds with a randomized sequence of compounds presentation. We performed different trials with quinine hydrochloride, sucrose and commercial masking solution.  The different independent experiments performed demonstrated the validity of the model to discriminate increasing concentration of bitter taste using quinine hydrochloride solutions while no differences were found when comparing different increasing concentration of sucrose with water.