跳至主要内容

Pharmaceutical Preformulation Studies

 

Preclinical Candidate Characterization

Solubility:

– pH Solubility Profile
– Solubility in Organic Solvents

– Solubility in Fasted State Simulated Intestinal Fluid (FaSSIF), Fed State Simulated Intestinal Fluid (FeSSIF) and Simulated Gastric Fluid (SGF)

Stability:

– Solution Stability, Solid State Stability, ICH Photostability

Inherent Properties:

– pKa, Log p/Log D, Intrinsic dissolution, etc.

Enabling Formulation Development for Screening

    – Vehicle Selection
– pH Adjustment and Co-Solvent
– Surfactant Solubilization
– Nanosuspension
– Microemulsion
– Amorphous Solid Dispersion

Medicilon brings the right equipment, facilities and highly dedicated formulation specialists to help you arrive at the optimal dosage form for your API and application. We ensure any forms we develop are scalable, compliant and commercializable for our customers.  For more details, please click preformulation studies.

Preformulation is a branch of pharmaceutical sciences that utilizes biopharmaceutical principles in the determination of physicochemical properties of a drug substance. The objectives of preformulation studies are to choose the correct form of your drug substance, evaluate its physical properties and generate a thorough understanding of the material’s stability under various conditions, leading to the optimal drug delivery system.

goals of preformulation

Medicilon offers a wide range of analytical approaches to achieve these goals. These approaches are designed to help moving your compound from drug candidate to marketable product.  We can test for a full spectrum of requirements including forced degradation studies, solubility, pH stability, polymorphism and unknown compound identification.

Preformulation Studies

We offer a full spectrum of Pharmaceutical Preformulation testing capabilities, including:

  • Solubility Studies
  • pH Stability Studies
  • Particle Size Analysis
  • Powder Flow Testing
  • Polymorphism Studies
  • Structural Identification
  • Forced Degradation Studies
  • Microstructural Analysis
  • Unknown Compound Identification
  • Analytical R&D
  • Technical Consulting

Preformulation: A stage of development during which the physicochemical properties of drug substance are characterized.

Some commonly evaluated parameters:

  • Solubility
  • Dissolution Behavior
  • Stability
  • Partition Coefficient
  • Ionization Constant (pKa)
  • Solid State Properties such as crystal forms/polymorphs, water sorption behavior, surface properties, particle size and shape and other mechanical properties, et. al.

Contact Us 

Email : marketing@medicilon.com
Tel : +86 021 58591500

Tips : Above is part of pharmaceutical preformulation studies and pharma preformulation companies . You can also CONTACT US with any question or enquiry you may have. We will be happy to discuss your needs in detail and design an appropriate plan of action.

标签：

评论

发表评论

此博客中的热门博文

Medicilon and Binhui Biopharmaceutical Have Reached a Strategic Collaboration to Jointly Draw a New Blueprint for the Development of New Biological Drugs

  On March 18, Medicilon and Binhui Biopharmaceutical (Binui Bio) announced a strategic collaboration.  The two parties will work together to jointly explore the possibilities in cutting-edge fields such as oncolytic viruses, nucleic acid drugs and protein drugs. Gather and Work Together to Create Advantages      Facilitate the Research and Development of Oncolytic Viruses, Nucleic Acids, Proteins and Other Drugs As a one-stop biopharmaceutical comprehensive preclinical R&D service CRO, Medicilon has been developing and accumulating for 20 years, always adhering to the spirit of innovation, and has successfully constructed bi/multi-specific antibodies,  ADCs ,  mRNA vaccines ,  small nucleic acid drugs ,  PROTAC , and  CGT technical service platform  that have helped 421 INDs obtain clinical approval.  It is this outstanding achievement that has earned Medicilon wide recognition in the industry and laid a solid foundation f...
发表评论
阅读全文

A Nickel-Catalyzed Reductive Alkylation of Aryl Bromides and Chlorides for Sp3-Sp2 Bond Formation

  In 2012, a nickel-catalyzed reductive alkylation method of aryl bromides and chlorides was reported. Under the optimized conditions, a variety of aryl and vinyl bromides as well as active aryl chloride can be reductively coupled with alkyl bromides in high yields. The protocols were highly functional-group tolerant and the reactions were not air or moisture sensitive. The reaction showed different chemoselectivity than conventional cross-coupling reactions. Substrates bearing both anelectrophilic and nucleophilic carbon resulted in selective coupling at the electrophilic carbon (R-X) and no reaction occurred at the nucleophilic carbon (R-[M]). The 2010 Nobel Prize in Chemistry was awarded for the Pd-catalyzed cross-coupling, and in the past decade the progress in cross-coupling has not only had a significant impact on academic research but has also influenced the industrial synthetic application. The transition-metal-catalyzed union of nucleophilic organo-boronic acids with elect...
发表评论
阅读全文

The Launch Meeting was Held by Medicilon and DAC Biotech of the Contract Research on ADC Preclinical Study

  Chuansha, Shanghai, Nov. 8th, 2019 — Medicilon held the launch meeting with Hangzhou DAC Biotech Co., Ltd to initiate the   preclinical study   of the antibody-drug-conjugate (ADC)  DXC005, including the   pharmacology study ,   DMPK study   and the   safety evaluation . Medicilon has previously completed integrated  preclinical research  on ADC drugs cooperating with DAC Biotech and other companies. Two of them has been approved by NMPA and entered Phase I clinical trials. About Hangzhou DAC Biotech Co., Ltd Hangzhou DAC Biotech, Co., Ltd was officially registered in HEDA Area, Hangzhou City, Zhejiang Province, China around the end of Year 2012, and is located nearby the bank of beautiful Qiantang River. The company focuses on developing conjugate of monoclonal antibody and small molecular cytotoxic drug, both of which are banded together with smart linkers. About Antibody-Drug-Conjugate (ADC) ADCs ...
发表评论
阅读全文