Sharp observation: Why is the powder direct compression process only popular in foreign countries?

Source: Internet (intrusion and deletion)

As early as 1992, a survey of 58 pharmaceutical companies in the United States showed that the direct compression method was more popular.
The survey results showed that 41.
4% of the companies said that direct compression was their first choice , and 41.
1% of the companies said that they use direct compression and In the two methods of wet granulation, 1.
7% of the companies said that they have never used direct compression, while 15.
5% of the companies believe that the process is not worth promoting
.
At present, the traditional wet granulation and tableting method is still the main method of producing tablets used by the pharmaceutical industry in China

Direct powder compression is to sieve and mix the powder of the drug and suitable auxiliary materials separately, and then directly compress them into tablets without curing the granules (wet granules or dry granules)
.
The process routes of tableting after granulation and direct compression are as follows:

Wet granulation and tableting process

Dry granulation and tableting process

Powder direct compression process

The powder direct compression process has so many advantages, why is it only popular in foreign countries and has not become the mainstream tablet production process in my country?

① In the past ten years, China has imported a large number of high-quality auxiliary materials that can be directly compressed, but the price is too expensive compared to domestic auxiliary materials
.
②The fluidity and compressibility of most domestic common excipients cannot meet the requirements of direct compression technology

According to the current "Administrative Measures for Drug Registration" (Bureau Order No.
28), supplementary applications should be submitted for "change of excipients in drug prescriptions that have been required for medicinal use" and "change of production processes that affect drug quality"

The fundamental resistance of the direct powder compression process in my country comes from the technology itself, these technologies mainly include:

Powder mechanical control of raw and auxiliary materials (such as compressibility, fluidity, dilution potential, content uniformity, lubrication sensitivity, etc.
);

It is not that no companies try the direct compression process.
A few companies use the direct compression process to improve the existing tablets.
Often they encounter various problems that cannot be solved during the pilot or scale-up production process, which causes this phenomenon.
The main reason is that the R&D personnel did not fully understand the direct compression process, did not formulate the necessary internal control standards for the powder state of the raw and auxiliary materials, did not formulate a reasonable product design space, did not conduct sufficient pilot and scale-up verification of its prescription and process, etc.

Suggestions for future development

• Promote enterprises to become the main body of R&D and cultivate the awareness that quality comes from design

• Promote the development of new auxiliary materials in China, and lay the foundation for the comprehensive promotion of powder direct compression technology

• Technical methods can be used to improve drug fluidity and compressibility

• The formulation design should follow the characteristics of the powder direct compression method

• Strict and feasible internal control standards for intermediates and finished products should be formulated

• The process should gradually undergo pilot, trial production and scale-up production verification

Reference source:

G.
Aldebo, Cui Fude.
Translations of foreign pharmacy monographs-Drug powder compression technology (Switzerland) (Chinese version)