Science Pool

The Twin Screw Wet Granulation (TSWG) is a manufacturing process gaining increased attention in the pharmaceutical industry due to its versatility, scalable nature, and seamless integration into continuous manufacturing lines. Especially advantageous in early pharmaceutical development, where API quantity is limited, TSWG accommodates small batch sizes, facilitating later large-scale campaigns using the same equipment. 
A DoE study was conducted in order to assess the influence of the main process parameters on the characteristics of granules and tablets. A leading formulation containing a soluble drug, namely Niacin, was used, and the factors evaluated in the DoE were the screw design, the screw speed, the Liquid/Solid ratio (L/S), the feed rate and the screen type. 
The responses evaluated were referring to the process (e.g. torque), the granules (e.g. particle size distribution (PSD), density and flowability) and the tablets (e.g. tensile strength, friability and disintegration time). This study provides critical insights into optimizing TSWG processes, ensuring efficient granule and tablet outcomes.

Download the poster, which was presented at AAPS PharmSci360 2023, for comprehensive details on the influential process parameters and their impact on granulation and tablet characteristics in TSWG.

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This text underscores the significance of Orally Dispersible Tablets (ODTs) for enhancing treatment compliance, particularly for patients with swallowing difficulties. Co-processed excipients for fast-disintegrating tablets (CPE-ODT) offer a convenient solution, combining a soluble filler and superdisintegrant. These can be efficiently blended with active ingredients, lubricants, and compressed into tablets, streamlining the development process. Investigating the relationships among compaction stress, compact solid fraction, and mechanical strength is crucial for optimizing tablet composition and speeding up development. Striking a balance between inter-particle bonding strength and porosity is especially vital for ODTs, ensuring rapid disintegration with sufficient mechanical resistance for downstream processes. The study aims to establish a general pre-formulation screening method by generating compressibility, compactibility, and tablettability profiles of CPE-ODTs blended with varying drug amounts. These data offer valuable insights into the impact of drug load on compression behavior and key properties, such as friability and disintegration time, facilitating the efficient development of ODTs.

Download this poster presented at AAPS PharmSci360 2023 for comprehensive details on this formulation screening approach.

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While simple combinations of dosage forms expedite access to First-in-human (FIH) studies, the demand for robust formulations and processes challenges quick development, particularly for tablet production. Early clinical phases face hurdles like dose uncertainty and limited active pharmaceutical ingredient availability. The study addresses these challenges by proposing a compressibility assessment method using small-scale experiments. The aim is to establish a pre-formulation screening approach based on compressibility data for active ingredients, utilizing round punches of varying diameters. By employing the smallest tooling, the study achieves a remarkable 75% reduction in the amount of active ingredient required for compressibility analysis.

Download our poster presented at AAPS PharmSci360 2023 to learn more

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Check out Evotec's infographic to learn more about our expertise with ASAP as well as with all-type stability studies.

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Check out Evotec's infographic on Aerodynamic Particle Size Distribution and learn how our dedicated team of scientists has the right experience in analytical inhalation to ensure accuracy and reliability. 

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INDiGO is the fastest and most efficient platform to bring a program from candidate selection through IND and beyond.

Once your clinical candidate is selected, this fully-integrated clinical-enabling package provides inter-disciplinary coordination of all aspects of drug development, conducted and managed by a dedicated Evotec team, and usually at a single Evotec site.

Key features:

•  Accelerating your drug discovery and research programs through interdisciplinary integration and expert coordination of all activities “under one roof”
• Industry-leading timelines, taking your program from the selection of an optimal clinical candidate to regulatory submission typically in less than 52 weeks
• Expert management by experienced, dedicated project managers and drug development professionals
• Seamless knowledge transfer across disciplines, maximizing the quality and efficiency of the overall development package
• Custom-designed, flexible development plans that allow for real-time adjustments and adaptability to unforeseeable scientific outcomes
• Excellence in project governance, performance review and issue escalation management

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Download this fact sheet to learn more about formulating your way to successful toxicology studies including:

• Early formulation
• Material science - solid development
• DMPK
• In vitro, in vivo, and in silico models

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E.SOLVE is Evotec's solution to accelerate your journey to the clinic supporting your formulation strategy as early as possible from discovery to market approval.

Download this fact sheet to learn more about how E.SOLVE's full range of approaches improve solubilization and bioavailability to ensure that your API can progress through the drug discovery development pipeline faster.

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Learn more about inhalation drug development at Evotec including:

• Integrated and stand-alone development plans tailored to your project
• Formulation development of dry powders and liquids designed to meet a quality target product profile (QTPP) with consideration of final commercial process
• Inhaled analytics, API, material science, cGMP maufacturing and quality assurance processes

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