How to ensure the quality of solid preparations?

In pharmaceutical products, solid preparations are widely used and have many varieties, accounting for 70% to 80%. Since the starting material of solid preparations is powder, in order to ensure the product quality of solid preparations and the smooth production process, drugs often need to be processed and treated, including crushing, grading, mixing, granulating, drying, tablet pressing, etc. Each step of unit operation is permeated with the application of powder technology.

It is pointed out in the industry that preparation technology and pharmaceutical equipment are the guarantee for the smooth operation of powder, and are also important tools to ensure the quality of preparation products. Therefore, it is very important to select appropriate auxiliary materials and adopt appropriate preparation technology and equipment.

Taking the preparation process of tablets as an example, it is a tablet solid preparation made by mixing and pressing drugs and appropriate excipients evenly. The preparation process of tablets can be divided into three steps: filling, compression and pushing. In order to ensure the quality of tablets, the influence of the powder properties of tablet materials on the formability of tablets should be considered in the formulation design and the selection of excipients, including the analysis of the fluidity, compression formability and quantification of tablet materials.

With the development of new excipients and efficient tablet pressing equipment, tablet production has entered an era of high efficiency, energy saving and high quality. In the process of tablet pressing, according to the different properties of the powder, granulation and tablet pressing method or direct tablet pressing method are generally adopted. Among them, the granulation and tablet pressing method can be divided into wet granulation and tablet pressing method and dry granulation and tablet pressing method.

Specifically, the wet granulation and tablet pressing method has low requirements on the powder properties of raw materials or excipients, which can solve the problem of insufficient powder properties of raw materials and excipients, obtain particles with good fluidity, and significantly improve the compression formability of drugs. However, the disadvantage of wet granulation is that it is not applicable to drugs that are unstable in damp and heat, and there may be sticky impact, top crack and other situations during tablet pressing.

The principle of dry granulation is to crush the mixture of raw and auxiliary materials into thin or large pieces for granulation. Granulation can also significantly improve the fluidity and compression formability, which is mainly an effective method for granulation of drugs with heat and humidity instability. However, this method has high requirements for the properties of the auxiliary powder. The auxiliary material should have good plastic deformation, good compression formability or the role of dry adhesive, otherwise it is easy to be broken into powder when crushing and granulating after tableting, and the yield of particles is not high.

In recent years, with the continuous development of modern science and technology, as well as the standardization of GMP and the promotion of QbD concept, powder treatment methods continue to penetrate into the preparation process of solid preparations. At the same time, as preparation technology and pharmaceutical equipment directly affect the quality of preparation products, under the background of higher and higher requirements for preparation products in the current pharmaceutical industry, it is a trend to upgrade preparation technology and improve pharmaceutical equipment.

At present, the domestic solid preparation equipment market is mainly occupied by foreign manufacturers such as Germany and Italy. Some manufacturers also plan to establish solid preparation process centers in China to provide domestic customers with personal services including improving their production processes, helping customers achieve mass production, and providing customers with training in equipment and processes.

Comparatively speaking, domestic solid preparation equipment manufacturers are mainly concentrated in the low-end market, and the competitive means are mainly low price war, with a small number. With the promotion of the consistency evaluation of generic drugs, the normalization of procurement in quantity, and the accelerated upgrading of the pharmaceutical industry, domestic solid preparation equipment will have a large space for growth.

From the perspective of trend, the industry believes that the continuous production mode is the development mode explored and practiced by many solid preparation enterprises at present, that is, from the time when raw materials are put into production to the time when finished products are made, according to the process requirements, each process is carried out sequentially. It is expected that this model will become a development direction of the industry in the next five years or so.

In this context, some domestic solid preparation equipment manufacturers have also actively deployed in recent years. If some enterprises say that in 2020, the company will focus on the "overall solution supplier of solid preparation intelligent factory" and the strategic layout of the big health industry, continue to deepen the pharmaceutical equipment market and intelligent logistics industry, and strive to become a whole line solution supplier of pharmaceutical equipment intelligent factory, and continue to promote the big health industry in depth.

Some enterprises have promoted the strategy of "one vertical, one horizontal, one platform" through years of layout, constantly enriched their product lines, enhanced their competitive advantages in the field of solid preparations, and built competitive overall solutions for solid preparations and pharmaceutical smart factories.

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