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[Technology and Achievements Introduction] Absorption Improvement Technology (Solid Dispersion Formulation)

[Technology and Achievements Introduction] Absorption Improvement Technology (Solid Dispersion Formulation)

Introducing representative formulation technologies along with specific examples! We will meet all your requests regarding CMC.

We would like to introduce Spela Pharma's "Absorption Enhancement Technology." By using solid dispersions with polymers, we improve bioavailability. We have successfully developed formulations using this technology and are applying it to investigational drugs targeting compounds in the development stage. Our company responds to all requests related to CMC from the early stages of development to application. Please feel free to contact us when needed. 【Features】 ■ Improved bioavailability through solid dispersions using polymers ■ Successful development of formulations using this technology ■ Application to investigational drugs targeting compounds in the development stage *For more details, please refer to the PDF materials or feel free to contact us.

  • Other contract services
  • Technology Development

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Business and technology of the formulation technology research department.

Business and technology of the formulation technology research department.

We will also introduce practical examples! We are engaged in the development of various formulations with high novelty and added value.

We would like to introduce our pharmaceutical formulation technology research department's business and technology. Based on the skills and experience cultivated through research and development at major domestic pharmaceutical companies, we can provide high-value-added formulation design and development tailored to the development stage (speed, cost, differentiation, novelty of formulations). We develop robust and cost-effective manufacturing processes with a focus on scaling up to high-quality, cost-competitive formulation supply and production scale, as well as preparing approval application documents (CTD Module 3). 【Features】 ■ Utilization of technologies realized and inherited by our research team at major domestic pharmaceutical companies ■ Implementation of various formulation developments with high novelty and added value ■ Extensive experience in continuous manufacturing approaches that contribute to rapid clinical trial drug production, packaging design, and packaging technology development *For more details, please refer to the PDF document or feel free to contact us.

  • Other contract services
  • Technology Development

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[Technology and Achievements] Technology of Release Control Formulations (Sustained Release Granules)

[Technology and Achievements] Technology of Release Control Formulations (Sustained Release Granules)

By combining two types of enteric-coated granules, we achieve longer exposure! It has received high praise from clinical settings.

Our company has achieved a formulation that combines two types of enteric-coated pellets, one for immediate release (IR) and the other for delayed release (DDR), to attain a longer effective plasma concentration for clinical purposes. This technology is currently applied to capsule formulations sold domestically and has received high praise from clinical settings. We respond to all requests regarding CMC from the early stages of development to application. Please feel free to contact us when needed. 【Features】 ■ Achieves longer exposure by combining two types of enteric-coated pellets ■ Releases the active ingredient faster under neutral conditions than under acidic conditions, maintaining high plasma concentration ■ Applicable to oral morphine extended-release formulations *For more details, please refer to the PDF materials or feel free to contact us.

  • Other contract services
  • Technology Development

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[Technology and Achievements] Technology for Controlled Release Formulations (such as Sustained Release Matrix Tablets)

[Technology and Achievements] Technology for Controlled Release Formulations (such as Sustained Release Matrix Tablets)

Achieve reduced Cmax and longer exposure! Introducing the mechanism of sustained release from Gelmatrix tablets.

We would like to introduce our technology for "Release Control Formulations (Extended Release Matrix Tablets, Gastroretentive Formulations)." Even with reduced dosing intervals, we achieve lower Cmax and longer exposure. We have successfully developed formulations using this technology and are applying it to investigational drugs targeting compounds in the development stage. We respond to all requests related to CMC from the early stages of development to application. Please feel free to contact us when needed. 【Features】 ■ Achieves lower Cmax and longer exposure even with reduced dosing intervals ■ Successful development of formulations using this technology ■ Application to investigational drugs targeting compounds in the development stage *For more details, please refer to the PDF materials or feel free to contact us.

  • Other contract services
  • Technology Development

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[Research Achievements] Paper published in AAPS PharmSciTech.

[Research Achievements] Paper published in AAPS PharmSciTech.

The paper by Yoshihiro Omachi from our company's Formulation Technology Research Headquarters has been published in the academic journal "AAPS PharmSciTech" issued by the American Pharmacists Association.

Gastric retention drug delivery systems (GRDDS) are a formulation technology that retains orally administered formulations in the stomach to gradually release the drug, thereby delaying the transition of the drug to the small intestine and sustaining drug absorption. However, drugs that are difficult to dissolve or unstable in acidic environments have been considered unsuitable for GRDDS. In this study, we designed a GRDDS combined with a self-microemulsifying drug delivery system (SMEDDS) for drugs that have issues with solubility and stability in the stomach.

  • Custom reactions and synthesis
  • Other contract manufacturing
  • Other contract services

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