By MEDELPHARM S.A.S
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Designing complex tablet forms with MEDELPHARM
MEDELPHARM’s STYL’One R&D Tableting Instruments and our scientific and technical department provide outstanding support and flexible solutions for tablet manufacturers to deal with the day to day challenges of complex oral sold dosage (OSD) forms.
These include simple mono-layer, multi-layer, tab-in-tab, and Minitab formats.
MEDELPHARM stand-alone solutions can address all tablet development stages, from early formulation characterization of API to high-speed multilayered formulation scale-up.
Multilayer tableting with STYL’One Evo
The MEDELPHARM STYL’One Evo tableting instrument is the world’s most versatile single-punch research press for R&D, scale-up and production support. This all-purpose instrument enables fast API characterization and single layer to multi-layer formulation development, even when working with only a few grams of powder.
Fully instrumented, the STYL’One Evo is a genuine compaction simulator that combines with Analis sophisticated software, enable scientists to explore design space (QbD) and optimize formulations with utmost efficiency.
STYL’One Evo’s sophisticated design can handle complex tablet forms of up to five layers incorporating three different powders thanks to the multi-layer module. Furthermore automatic core feeding system allows tab-in-tab formulation designs.
MEDELPHARM has developed Analis as one of the world’s most comprehensive data acquisition and analysis package suitable for every formulation scientist.
The Analis R&D package drives the tablet press, acquires all the data and generates reports. Pre-defined compression profiles allow the user to mimic rotary production presses. Analis enables to control the STYL’One Evo in force or displacement mode to fulfil any R&D needs.
The Analis platform supports a range of modules that offer a wide range of solutions such as of Roller compaction mimicking, multilayer and tab-in-tab.
The Tablet test tester connection capability is particularly useful to save time and avoid mistakes while performing automatic studies and formulation screening.
MEDELPHARM Science Lab
The more complex challenges of formulating advanced OSD forms are supported by the work of the MEDELPHARM Science Lab that specializes in the technical aspects of API & excipient characterization, formulation design and development, implementing DoE methodology in tableting, optimizing key production process parameters and feasibility assessments.
In complex tablet forms, some of the Science Lab’s support can include:
- Multi-layer: Characterization of different layers to design a robust multi-layer formulation, testing multilayer formulations at target production speeds, evaluating critical process parameters such as tamping force for good adhesion between layers, and producing pilot batches for analytical method development, early stability or marketing prototypes.
- Tab-in-Tab: Dry coated or compression coated tablets composed of an inner core and an outer shell are designed to release APIs at different rates. Science Lab can help with production, testing the tab-in-tab formulation at equivalent production speeds, and evaluating critical process parameters such as core centering that can impact dissolution profile.
- Minitabs: Mini tablets with diameter smaller than 3 mm represent a new trend in solid dosage form design that offers advantages in dose flexibility and combined various release kinetics. However, designing mini-tablet formulations requires specialized technology, tooling and expertise, such as MEDELPHARM Science Lab’s mastery of using mono-tip punches in conjunction with innovative dual scale force measurement, rapid screening of formulations, and production of homogeneous small batches using multi-tips tooling and MEDEPHARM’s innovative force feed shoe.
- Longitudinally compressed tablets (LCTs): An LCT such as a multilayer osmotic pump formulation can be configured to contain several layers containing either different drugs or API concentrations. Here, Science Lab can help in producing LCTs with up to five layers and three products, evaluating critical process parameters for a multi-layer tablet, or producing small batches for experimental laser drilling.
- Orally disintegrating tabletor orally dissolving tablet: ODTs are single unit dosage forms that are designed to be placed and dispersed in the mouth without additional water. MEDELPHARM Science Lab can support manufacturers in selecting the optimum excipients to achieve fast disintegration and acceptable mouth feeling, rapid formulation screening to achieve ideal balance between tablet robustness and rapid disintegration, and evaluating the process parameters such as compression pressure that are critical for disintegration time.