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

What is preclinical testing?

In the process of  preclinical testing  of a compound or biological agent into a drug, the compound involved must go through the testing phase. First, we need to identify potential targets that can treat the disease. Then, a variety of compounds or preparations are screened out. Any compound that has shown potential as a drug for the treatment of this disease needs to be tested for toxicity before clinical testing to reduce the possibility of injury. preclinical testing What is the basis of preclinical testing? According to US Food and Drug Administration (FDA) regulations, a series of tests are required before a new drug is approved for use. In the first stage, basic research determines a hypothetical target for the treatment of a certain disease, and then screens small molecules or biological compounds to discover any substance with the potential to treat the disease. Then, a  preclinical research  phase followed, before which, as described above, the potential tox...
发表评论
阅读全文

Inventory of the three major in vitro pharmacokinetic research methods

  The metabolic properties of a compound are an essential factor in whether or not it can be used as a drug in the clinical setting, so pharmacokinetic studies of newly synthesized compounds are required in drug development. In vitro incubation with liver microsomes, recombinant CYP450 enzyme lines, and in vitro incubation with hepatocytes are some of the more common in vitro drug metabolism methods. 1. In vitro incubation method with liver microsomes The metabolic stability and metabolic phenotypes of candidate compounds in different species of liver microsomes are good predictors of the metabolic properties of compounds in vivo. They are practical tools for evaluating candidate compounds in the pre-development phase of drug development. Liver microsomes include rat liver microsomes, human liver microsomes, canine liver microsomes, monkey liver microsomes, and mouse liver microsomes. In in vitro incubation of the liver, microsomes are the "gold standard" for in vitro d...
发表评论
阅读全文

Enzyme Activity Assay Service

  Enzymatic assay Lance Assay Alphascreen Assay Z’-LYTE Assay Adapta Assay Kinase-Glo Assay ADP-Glo Assay Ligand Binding Assay ELISA Assay HTRF Assay Enzyme activity assays  are laboratory methods for measuring enzymatic activity. They are vital for the study of enzyme kinetics and enzyme inhibition. Enzyme units : Amounts of enzymes can either be expressed as molar amounts, as with any other chemical, or measured in terms of activity, in enzyme units. Medicilon provides various  enzyme activity assays  for  kinases , phosphatases, proteinases, deacetylase, peptidase, esterase, and other enzymes. Our line of well-characterized immunoassays and biochemical kits ensures accurate and reproducible results. Enzyme is a  large category of bio-molecules  that catalyze various biological processes including metabolic processes, cellular signaling and regulation, cell division and apoptosis. Enzymatic reactions convert substrate molecules into chemically modifi...
发表评论
阅读全文