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R&D
Quickly catching market needs and information, the R&D Div. is engaged in product development, ranging from synthesis of APIs to the prescription design of formulation (pharmaceutical) products.
R&D is a key process in pharmaceutical product development. It is not too much to say that the level of R&D for a pharmaceutical product determines the quality of the product.
Since formulation products are used directly on the human body, their safety, effectiveness, and quality must be ensured. This division develops APIs and formulation products that can meet increasingly stringent quality standards in the world, leading to the manufacture and supply of high-quality APIs and formulation products that are required by society and will be of help to patients.
APIs: (Components of) active pharmaceutical ingredients contained in formulation (drug) products
Formulation products: Drug products made by adding inactive ingredients, such as lactose and starch, to APIs and processing the mixture into tablets and granules
Office area
Approximately 80 employees work in the administrative operations area of the Research and Development Department. In addition to the development of active pharmaceutical ingredients (APIs) and pharmaceutical formulations, the Research and Development Department is also responsible for establishing testing methods and specifications, as well as handling regulatory affairs, including approval applications for development products. For this reason, close collaboration both between and within Department is essential.
By ensuring appropriate information sharing, we support rapid development and continuous improvement.
A cafeteria space is located on the second floor, where it is used not only for meetings but also as a place for employees to have lunch breaks and to promote communication among colleagues. A similar space is also available on the fourth floor, offering a panoramic view of the Tateyama Mountain Range.
Automatic reactor
API development requires many experiments in a limited amount of time.
This automatic reactor has two reaction tanks, which makes it possible to control two separate sets of reaction conditions via personal computer. When used with various inline sensors, this reactor is useful for efficient data acquisition.
Flow micro reactor
At Daito, we are also exploring continuous flow synthesis.
By using microreactors, reaction parameters can be easily adjusted. This enables us to investigate reaction conditions that are difficult to achieve in conventional batch-type experiments, where all raw materials are charged at the outset, leading to the discovery of new possibilities for the future.
Synthesis Laboratory Area
In the synthesis laboratory, we conduct a wide range of synthetic research, from exploring synthetic routes to optimizing reaction conditions, all within fume hoods. Researchers advance their studies in an environment that balances safety and operational efficiency by making full use of various reaction apparatuses and analytical instruments. In addition, as the synthesis area of the Active Pharmaceutical Ingredient (API) Research Laboratory, we also carry out studies with a view to scale-up and research aimed at establishing manufacturing processes, enabling integrated development from fundamental investigation through to practical application.
These facilities and organizational capabilities support continuous technological advancement and rapid research response toward the creation of high-quality APIs.
Dissolution bath
A dissolution bath measures both the time it takes for drug substances in a formulation product to dissolve and the dissolution rate under conditions (pH) similar to those in the human body.
Drug substances in a formulation product in oral solid dosage form dissolve in digestive tubes and are absorbed into the body and carried by the flow of blood to show their effect.
If both the time it takes for a copy product in tablet form to dissolve and its dissolution rate are equivalent to those of its original product, the effectiveness, safety, and quality of the copy formulation product are considered to be equivalent to those of the original formulation product.
LCMS-IT-TOF
LCMS-IT-TOF is a device that combines a liquid chromatograph (LC) and a mass spectrometer (MS).
After separating materials, LCMS-IT-TOF can detect each ionized material. LCMS-IT-TOF has an ion-trap (IT) time-of-flight (TOF) mass spectrometer, which enables accurate molecular weight determination.
We not only analyze synthesized APIs but also estimate the structure of trace impurities contained in their raw materials and intermediates and utilize the results for quality improvement.
NMR
An NMR (nuclear magnetic resonance spectrometer) is used to determine the structure of a material. This analytical piece of equipment is commonly used and indispensable in organic synthesis.
We use an NMR not only to analyze synthesized APIs but also to determine the structure of trace impurities contained in the APIs. Since an NMR can be also used for measurements of solids, we sometimes use it to analyze the crystal polymorphism of APIs.
20-liter reactor
In API development, we conduct many experiments to establish an API manufacturing process and then transfer the technology to an API factory. At this final stage, we use a 20 liter reactor to conduct test production. Designed with a manufacturing plant in mind, a 20-liter reactor enables you to assess various possible impacts that cannot be identified in small-scale experiments, which makes it possible to prevent incidents at API factories.
Fluid-bed granulator and dryer
A fluid-bed granulator and dryer is a device that supplies heated air from the bottom of the unit to suspend and fluidize powder particles, while spraying a binder solution to bind the particles together (granulation) and dry them simultaneously. By converting powders into granules, it is possible to improve flowability, ensure uniformity of the active ingredient, and enhance ease of ingestion and stability.
Tablet press
This is a small-scale tablet press used for experimental purposes in pharmaceutical formulation research. During the development stage, prototype tablets are produced on a small scale while varying formulations and manufacturing conditions. Developing a deep understanding of formulation characteristics at this stage leads to stable production in the future.
Electron microscope
An electron microscope enables you to easily observe objects magnified 500 to 2,000 times.
We use this device mainly to observe the crystal surface of APIs. The slightest difference in crystallization conditions causes difference in the particle size of APIs, which greatly influences the physical properties of the formulation product manufactured from the APIs.
With an electron microscope, we observe the crystal surface of APIs, which is useful to assess the manufacturing conditions of the APIs. We evaluate the particle size of APIs also when considering how to improve the dissolution test of the formulation product to be manufactured from the APIs.
ICP-MS
ICP-MS (Inductively Coupled Plasma Mass Spectrometry) is an analytical instrument that ionizes elements in a sample using a high-temperature plasma and enables highly sensitive detection down to trace levels through mass spectrometric analysis. In pharmaceutical research, it is widely used for controlling elemental impurities and for trace metal analysis in active pharmaceutical ingredients (APIs) and formulations, making it an essential technology for quality evaluation and the establishment of specifications.
Process Development Building
In this building, we conduct research and development on industrialization* processes, including studies on API industrialization and analytical methods.
* Industrialization means to review the manufacturing methods and locations of already commercialized products in an attempt to improve yield rates and workability.
High Potent R&D Center
Established in 2017, this facility is designed to ensure the safe and efficient research, development, and testing of highly potent active substances. Test laboratories are located on the first and third floors, providing environments suitable for a wide range of evaluation studies. The second floor is equipped with laboratories for active pharmaceutical ingredients (APIs), as well as facilities for formulation prototyping and small-scale manufacturing, enabling the production of investigational medicinal products (formulations). Through these capabilities, we have established an integrated development framework that spans from API manufacturing to pharmaceutical formulation production.