Why the Shift from Batch to Continuous for Pharmaceutical Oral Solid Dosage Form Tablet Manufacture is Now Upon Us.
Tablet land is beneficial to add strength and durability to the punch tip. But, this hand land may be perceived as making it more difficult to coat the tablet.
In this case study, API (X) is a highly insoluble compound with a particle size of approximately 14 microns and targeted as a powder for oral suspension dosage form.
Rapid and consistent in-vivo drug dissolution is critical for drug absorption. In-vitro dissolutions tests are used to predict in-vivo disintegration and dissolution properties of drug products. The in-vitro disintegration and dissolution times of tablets and capsules can vary significantly based on their composition and processing.
As stated in the International Conference on Harmonisation Harmonised Tripartite Guidance on Pharmaceutical Development, ICH Q8 (R2), “The aim of pharmaceutical development is to design a quality product and its manufacturing process to consistently deliver the intended performance of the product.”1 Several tools are available as guidance issued by FDA such as “Quality Systems Approach to cGMP Manufacturing”2 that includes ideas such as Quality by Design (QbD) in the development process. This guidance, amongst others, lay the framework for expectations of regulatory reviewers in their examination of client submittal documentation.
The pharmaceutical industry has undergone a sea of change in recent years as manufacturers have adapted to the end of the era of large-volume production of mass-market blockbuster drugs. With firms now focusing in on subpopulations of patients, there is a need for lean, adaptable facilities that can switch quickly between multiple products in multiple formats. Modular facilities can meet this need. While not a panacea, for the right project characteristics, ‘Modularity in Design’ can deliver significant and quantifiable long-term value.
Porosity can help predict deformation properties during compression, pharmacokinetic behavior within the body, shelf life, moisture penetration, and bioavailability.
Natoli Engineering Company, Inc. provides high quality tablet compression tooling, presses, parts, accessories, and services to the nutritional/vitamin supplement industry. With more than 40 years of industry experience, we are uniquely qualified to meet your tableting needs.
High performance tablet deduster for largest dedusting capacities equipped with the latest technology combined with a metal detector by Ceia or Lock. Tablets are dedusted and conveyed with our unique acceleration control and helix in the most sensitive way.
Ideal for production of middle-sized charges and research applications.
Manual 2-way diverter used for continuous filling of containers with tablets or capsules.
Compaction and granulation machine for the chemical industry.
The Alexanderwerk PP 150 C is especially designed as a machine which meets the highest requirements and standards of the chemical industry. As the smallest Alexanderwerk model for the chemical sector it provides a roller diameter of 150 mm and a roller width of 75 mm. With a throughput up to 400 kg/h the PP 150 C can be used in a test center, for the research and development as well as for the production.
Easy scale-up
The Solidlab 2 laboratory machine handles batch sizes from 0.25 to 12 kilograms in laboratory scale. The different modules use a common periphery and are constructed like full scale production machines. This enables an easy scale-up of all production parameters.
The Solidlab 1 laboratory machine processes batch sizes from 0.05 to 1 kilograms and is the equivalent for the highest performance in the smallest space. The plant supports you in developing your products and in examining your recipes. All important parameters and results are recorded by the software, and changes are documented. This makes the Solidlab 1 the ideal solution for your feasibility studies.
The Manesty XL Cota 750 is designed for larger batch production and has the same proven benefits in operation as the smaller 150 and 350 sizes. Dependability and reliability are key attributes for this size of batch and with a proven installed base, the XL Cota 750 is again ideally suited for all tablet coating requirements. With segmented drum technology the efficient coating of pellets and seed API’s is also possible.
