Misunderstandings In The Process Development Of Solid Preparations

Part 1 Is In Place In One Sep Without Screening

Usually, in order to find the best combination, a prescription development process is often accompanied by a large number of screening tests, and the popular DoE in recent years is a representative of this model. However, some companies lack the corresponding capacity accumulation or are afraid of spending money. Even if the scale increases, it is still a guerrilla style of play. Instead of relying on screening, they hope that the developers will come up with a “feasible” prescription process. How to deal with how to do it in the past, the “national standard drugs” that are difficult to fail are still passable, and the real generic drugs that are “imitation products are not imitation standards” are often unable to do what they want. It’s nothing more than an easy-to-make product. Some preparations are more difficult, and the trial and error are unsuccessful. The point is that there is almost no reference value for subsequent development and production, not to mention the waste of time.

Part 2 Follow The Feeling

A prerequisite for the screening test is relatively accurate result feedback and analysis, otherwise it is very likely that the gold rush will be washed away with the sand. Some master craftsmen still insist on relying on visual inspection and hand feeling. The fluidity is acceptable…the compressibility is good…the mixing uniformity is okay…this kind of people make it The product knowledge obtained by the prescription process is seriously insufficient. The whole process is like a black box, with processes without boundaries, neither knowing whether the fluctuation is good or not, nor how to make it better. As production progresses, changes accumulate, and when they suddenly break out, they are often caught off guard and cause accidents, which have very limited reference value for the commercial production stage.

Many companies think that I understand how many years I have been working on this product. In fact, they don’t understand. You may know that ten parameters have an impact, but you don’t know how big the impact is. If there is a problem, do some useless work on a secondary project. It’s like when you’re taking an exam, you’re stuck on a multiple-choice question, but you don’t have time to do the basic questions, so you can get a high score?

Part 3 Focus On Qualification And Light Production

Some people declare for registration, and everything is aimed at meeting the inspection standards, regardless of the applicability for production. I feel that I am buying time for the company. Anyway, after the approval documents are rotten in the pot, am I doing it slowly? As a result, production blamed R&D for broken craftsmanship, and R&D blamed production for not cooperating.

Part 4 Blindly Pursue Advanced Level

Some people blindly worship the advanced level. When I heard others say how excellent and energy-saving powder compaction is, developed countries accounted for half of the prescription, so I was so excited that I wanted powder compaction no matter what the prescription was. But if you look back and think about it, are all products really suitable for powder compression? Powder compression requires such high equipment, can you do it? Ordinary products with a granulation process have relatively low requirements on the properties of raw and auxiliary materials, because the granulation process is a modification process, and after granulation is removed, it completely depends on the particle size distribution, tightness, crystal form, etc. of the raw and auxiliary materials. It is equivalent to handing over the lifeblood of the product to the upstream. The terrible thing is that many upstreams do not realize how important their impact on the downstream is. Maybe a small change from him may ruin your fortune. Looking back, are these highly recommended manufacturers all imported accessories and equipment? Would you buy such an expensive product if it is not of a high level? People are running in sneakers and you are running in high heels. It’s no different when Bolt is here. Mr. Xie said that the relevant substances are smoke bombs from developed countries. In fact, powder compression, hot melt Extrusion, pellet compression, osmotic pump controlled-release tablets, etc., are much older smoke bombs.