Pharmaceutical Excipient Analysis Service

Pharmaceutical Excipient Analysis Service

Catalyzing Formulation Success: Count on CD BioGlyco for Cutting-edge Pharmaceutical Excipient Analysis

At CD BioGlyco, we offer a comprehensive suite of cutting-edge analytical solutions for carbohydrate-based pharmaceutical excipient analysis. We understand the crucial role that excipients play in drug dosage forms and their impact on the overall effectiveness of the product.

Why Do We Offer This Analysis Service?

Pharmaceutical excipients are essential non-active components incorporated into Pharmaceutical formulations, apart from the active drug ingredient. Although excipients are typically inert and lack therapeutic activity, they are vital for facilitating the manufacturing process and ensuring the efficacy of the end product. There are situations where specific active ingredients or drugs may have restricted bioavailability or inadequate absorption in the human body. As a result, we analyze them comprehensively to help clients develop suitable pharmaceutical dosage forms to address these issues.

Fig.1 Pharmaceutical excipient analysis at CD BioGlyco. (CD BioGlyco)Fig.1 Pharmaceutical excipient analysis at CD BioGlyco. (CD BioGlyco)

We have dedicated extensive research to carbohydrates over the years, recognizing their importance as pharmaceutical excipients. Carbohydrates play a myriad of crucial roles in drug formulation, including enhancing stability, improving solubility and bioavailability, and facilitating drug packaging and delivery, among others. Our research aims to further understand the functionality and applications of carbohydrate excipients, ultimately aiming to help clients improve drug efficacy in research and development.

Fig.2 Carbohydrates used in polymeric systems for drug delivery. (Di, et al., 2022)Fig.2 Carbohydrates used in polymeric systems for drug delivery. (Di, et al., 2022)

We provide an extensive range of analysis services for a diverse selection of carbohydrate excipients. Moreover, our inventory includes a wide array of high-quality Carbohydrate Products.

Our excipient analysis service focuses on providing detailed analysis and characterization of various excipients used in pharmaceutical formulations. We utilize state-of-the-art analytical to assess the quality, purity, and performance of excipients. Analyzing their information regarding the performance of excipients helps in substantiating the drug product specification and also justifies the selection and quality of the excipients. Our team of experts has extensive experience in excipient analysis and thoroughly understands the regulatory requirements and industry standards. We offer a wide range of analytical services to support the characterization and evaluation of excipients, including:

  • Identification and purity analysis: We employ techniques such as chromatography, spectroscopy, and mass spectrometry to accurately identify and quantify excipients and potential impurities.
  • Physicochemical properties analysis: The physical and chemical properties of excipients, such as particle size distribution, surface area, solubility, and pH, are investigated to ensure their suitability for specific dosage forms.
  • Compatibility analysis: The compatibility of excipients with active ingredients is evaluated to identify any potential interactions that may impact product stability, efficacy, or safety.
  • Dissolution and disintegration analysis: We assess the performance of excipients in tablet formulations by analyzing their effect on dissolution rates and disintegration times, ensuring optimal drug release.
  • Stability analysis: Stability analysis is conducted to assess the effect of excipients on the stability and shelf-life of pharmaceutical products, thereby ensuring the quality of the product throughout its lifecycle.

Publication Data

Technology: Raman spectroscopy

Journal: Analytical Methods

IF: 3.1

Published: 2021

Results: The article discusses the application of Raman spectroscopy for quantitative analysis in solid pharmaceutical preparations. The authors proposed the use of label-free Raman spectroscopy combined with deep learning (DL) and non-negative least squares (NNLS) as a solution to address the bottleneck in fast drug screening. This bottleneck is not only a challenge in drug administration, but also a significant scientific challenge associated with the presence of falsified and/or substandard medicines. The results demonstrated that Raman spectroscopy remains a cost-effective, rapid, and user-friendly method for identifying compositions in excipient-dominated drugs. By combining it with DL and NNLS, it enables fast implementation in the identification of lactose-dominated drug (LDD) formulations. Additionally, Raman spectroscopy, when paired with the peak matching method, allows for visual interpretation of the spectral signature, including the presence or absence of active pharmaceutical ingredients (APIs) and low content APIs.

Fig.3 Raman spectra of the LDDs (left) and their excipients (right). (Fu, et al., 2021)Fig.3 Raman spectra of the LDDs (left) and their excipients (right). (Fu, et al., 2021)

Frequently Asked Questions

  • Why are pharmaceutical excipients important in a pharmaceutical product?

Pharmaceutical excipient plays a crucial role in modern drug products. Firstly, some excipients are responsible for the delivery system of the drug, ensuring that it reaches the intended site in the body for maximum effectiveness. Others prevent premature release of the drug, particularly in areas where it could cause irritation or upset the stomach. Excipients also aid in the disintegration of the drug into small particles, facilitating quicker absorption into the bloodstream. Additionally, excipients play a vital role in maintaining the stability of the product, ensuring it remains effective until it is used. Some excipients are used to aid in the identification of the drug product, while others improve the taste and appearance to enhance patient compliance.

  • What characteristics should pharmaceutical excipients possess?

Pharmaceutical excipients should display physiological inactivity and chemical stability. These substances must also be free from microbial contamination and not interfere with the bioavailability of the drug.

  • What is the classification of pharmaceutical excipients?

Excipients can be categorized into various functional groups based on their roles in pharmaceutical formulations. These groups include binders, solvents, fillers, disintegrants, lubricants, surfactants, emulsifying agents, suspending agents, antimicrobials, preservatives, and others.

  • What forms of pharmaceuticals can carbohydrate excipients be applied?

Carbohydrates are extensively utilized in the formulation and functioning of a wide range of medications, including tablets, capsules, liquids, suspensions, gels, inhalation products, and strips.

Applications

  • By our analysis, valuable information about the physicochemical excipients is acquired. This data can be used in the selection and optimization of excipients for the development of safe and effective drug formulations.
  • Our analysis involves identifying and measuring impurities, such as those related to the manufacturing process, leftover solvents, and products of degradation. This guarantees the safety and effectiveness of the pharmaceutical end product.

Advantages

  • Our research team has many years of experience in excipient analysis and understands the industry standards.
  • We possess diverse advanced analytical technologies and ensure accurate identification, quantification, and assessment of excipient properties.
  • We actively seek feedback from our clients and invest in the latest technology and training to enhance the quality and efficiency of our excipient analysis services.

At CD BioGlyco, our Pharmaceutical and Biological Analysis Service is tailored to meet the specific needs of our clients, aiming to help clients with the research and development of drugs. Through our comprehensive analysis and evaluation, we strive to empower our clients to make informed decisions that contribute to the development of pharmaceutical products that are both safe and effective. We understand the importance of excipients in drug development and ensure that our clients have the necessary information and support to optimize their drug formulations. If you would like to learn more about our services or discuss your specific needs, contact us without hesitation.

References

  1. Di, X.; et al. Carbohydrates used in polymeric systems for drug delivery: from structures to applications. Pharmaceutics. 2022, 14: 739.
  2. Fu, X.; et al. Quantitative analysis of excipient-dominated drug formulations by Raman spectroscopy combined with deep learning. Analytical Methods. 2021, 13(1): 64-68.
This service is for Research Use Only, not intended for any clinical use.

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