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The main products are food additive microcrystalline cellulose, food additive magnesium stearate, food additive sodium carboxymethyl starch, food grade magnesium stearate, food grade sodium carboxymethyl starch microcrystalline cellulose, Magnesium stearate, sodium carboxymethyl starch, pregelatinized starch, starch, dextrin, etc.
11
2022
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05
What are the research and development approaches for pharmaceutical excipients? Pharmaceutical excipient suppliers explain.
Pharmaceutical excipient suppliers believe that at present, in addition to improving the quality of traditional excipients, new excipients have also been developed, including microcapsules and nanocapsules; microspheres, nanospheres, liposome carrier materials, sustained-release, controlled-release and targeted drug delivery materials; inclusion compounds, film coating materials; prodrug carrier materials; solid dispersion carrier materials; magnetic carrier materials; film-forming materials; plasticizers; propellants; permeation enhancers; surfactants, etc., covering more than 40 major categories and thousands of varieties.
Pharmaceutical excipient supplierIt is believed that at present, in addition to improving the quality of traditional excipients, new excipients have also been developed, including microcapsules and nanocapsules. Microspheres, nanospheres, liposome carrier materials, sustained-release, controlled-release and targeted drug delivery materials; inclusion compounds, film coating materials; prodrug carrier materials; solid dispersion carrier materials; magnetic carrier materials; film-forming materials; plasticizers; propellants; permeation enhancers; surfactants, etc., more than 40 major categories and thousands of varieties.
Pharmaceutical excipient suppliers believe that taking solid dosage excipients as an example, the research and development of pharmaceutical excipients in recent years has mainly followed three approaches:
1. Development of completely new pharmaceutical excipients (new chemical drugs).Pharmaceutical excipient supplierIt is believed that since the 1990s, relatively few new pharmaceutical excipients have been developed, mainly because the development of new excipients takes a long time, requires various approval procedures, and has a long approval time. The safety and toxicity must also be assessed. After approval, the product needs to be promoted to pharmaceutical companies and the product market needs to be expanded. The long research cycle, high risk, high investment, and low return rate of new excipients have also affected the research and development of pharmaceutical excipients to some extent. In the future, in the field of solid dosage excipients, collaborative research and development between excipient developers and pharmaceutical companies will become the direction of development for pharmaceutical excipient research and development models.
2. Changing the morphological parameters of existing excipients to develop new excipients. Pharmaceutical excipient suppliers believe that each solid substance has specific morphological parameters, such as molecular arrangement state (crystalline form, polymorphism, amorphous form, etc.), particle state (particle type, particle size, surface area, porosity), bulk density, etc. These physical properties are interrelated. Changing one parameter will affect other parameters, which provides guidance for developing new specifications of accessories and combining various accessories to prepare new accessories.
By changing the morphological parameters of excipients, a series of new excipients have been developed, such as different particle sizes: spray-dried microcrystalline cellulose, spray-dried lactose, pregelatinized starch, and dibasic calcium phosphate for direct compression. Compared with the original excipients, the new excipients have significantly improved particle shape, particle size, particle size distribution, specific surface area, surface free energy, and compressibility. These novel excipients have good flowability and compressibility and can be used for direct compression, simplifying the production process and eliminating the impact of factors such as wet heat during production on drug stability.
3. Joint application of various excipients to develop new excipients.Pharmaceutical excipient supplierIt is believed that the joint application of two or more auxiliary materials to develop a new auxiliary material mainly uses the synergistic effect through the interaction between materials at the molecular level to overcome the shortcomings of auxiliary materials.
Pharmaceutical excipient suppliers believe that in recent years, many monographs on new drug release technologies, research and application results of new technologies, and research and application of pharmaceutical excipients have been published, which has also strongly promoted the application of new excipients and the research and development of new drugs.
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