Hebei Weimiao Biology Co., LTD 1
Beliggenhed
  • API Synthesis

apr . 26, 2024 12:06 Tilbage til listen

API Synthesis



API Synthesis

What is Active Pharmaceutical Ingredient?

Active Pharmaceutical Ingredient (API) is defined by U.S. Food & Drug Administration as: any substance or mixture of substances intended to be used as the active ingredient in the manufacture of a drug (medicinal) product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or function of the body.

API may exist in the form of liquids, powders, crystals and extracts that obtained by chemical synthesis, plant extraction, or biotechnology and is not taken by patients directly. Only when API is processed into a pharmaceutical preparation, can the product be used for clinical use. The synthesis of APIs is usually a complicated and multi-step process involving numerous chemical transformations and operations on a range of raw materials with different physical and chemical properties. Specialized expertise is needed to achieve the synthesis of these molecules. BOC Sciences with seasoned chemists would provide a comprehensive supply of guaranteed API synthesis service.

Types of Active Pharmaceutical Ingredients

The categorization of Active Pharmaceutical Ingredients (APIs) is a multifaceted endeavor, dependent on their unique chemical architecture and origin. To that end, the triumvirate of API classes is: Synthetic APIs, Biologic APIs, and Natural APIs.

Synthetic APIs, for instance, are purposefully crafted to emulate the intricate design and functionalities of natural compounds, including proteins, enzymes, and hormones. Notably, the pharmaceutical industry widely employs these APIs as they possess a facile manufacturability, longevity, and can be tinkered with to optimize their unique features.

Conversely, Biologic APIs are procured from living organisms, namely cells, tissues, or microorganisms, making their molecules markedly intricate and necessitating unique fabrication techniques, like cell culture, fermentation, and purification.

Lastly, Natural APIs are extracted from organic resources like plants, animals, or minerals. Natural APIs have emerged as potential sources of new drugs, albeit with the notable tradeoff of being less potent and specific than their synthetic or biologic counterparts. Nonetheless, natural APIs exhibit the salient benefit of being more readily obtainable and frequently induce fewer side effects.

High Quality 99% SR-9009 Cas 1379686-30-2

Methods of API Synthesis:

Inorganic synthesis

There are certain inorganic molecules can be used as active pharmaceuticals ingredients. Taking the aluminium hydroxide (the synthesis route is displayed as below) as an example, which is a typical inorganic API that reacts with excess gastric acid to reduce the acidity in the stomach, it can significantly relieve the symptoms including ulcer, indigestion and heartburn.

2NaOH + CO2 = Na2CO3 + H2O
NaAl(OH)4 = Al(OH)3↓+NaOH

Overview of our API Development Process

The initial phase of Active Pharmaceutical Ingredient (API) development necessitates the identification of a prospective target molecule that can trigger the desired therapeutic effect, known as Target Identification. This primary stage can be executed using an array of methods, including target-based screening, phenotypic screening, or computer-aided drug design, to name but a few.

Once a target molecule has been pinpointed, the next phase is to increase its efficacy and diminish its toxicity by optimizing its properties, a process referred to as Hit-to-Lead Optimization. Consequently, researchers endeavor to synthesize and assay a sequence of analogs or derivatives of the target molecule to pinpoint the most promising lead compound.

Following the identification of the lead compound, researchers initiate Lead Optimization, whereby the optimization procedure amplifies its pharmacokinetic and pharmacodynamic properties by modifying its chemical structure. Modifications are geared toward enhancing the compound's absorption, distribution, metabolism, and excretion.

Upon the successful completion of Lead Optimization, preclinical development ensues, whereby the optimized lead compound is evaluated in preclinical models to gauge its safety, efficacy, and pharmacokinetics. Animal models, such as rats or mice, are employed to determine the compound's toxicity and effectiveness, and to verify the feasibility of progressing to clinical trials.

Lastly, once the lead compound is deemed safe and effective, API Manufacturing begins, necessitating several manufacturing steps, including synthesis, purification, and characterization, to yield a high-quality API.

Del

Hvis du er interesseret i vores produkter, kan du vælge at efterlade dine oplysninger her, så kontakter vi dig snarest.


da_DKDanish