LFHC technology as a solution to the global shortage of pharmaceutical raw materials
The pharmaceutical industry, like many others, has been facing shortages of raw materials and medical components since the onset of the pandemic in 2020.
Although some sectors have managed to improve their product supply and shipping logistics over the months, recent international and health circumstances have caused shortages to intensify again.
Unfavorable circumstances
Some of the scarcest materials in 2022 that can affect the production of finished pharmaceutical products are active pharmaceutical ingredients or APIs. The main reason for this is that Approximately 80% of all APIs produced in the world come from India and China.
This has been a major drawback since the beginning of the pandemic, as many pharmaceutical producers in the world depend on Asian APIs, which have been greatly affected by the lack of labor for their production or the scarcity of raw materials at a global level.
Additionally, we have the problem of international supply and logistics disruption, which has been going on since 2021 and is currently exacerbated by the closures of Chinese companies and cities (due to recent outbreaks of the virus), and is expected to continue well into 2023.
As if that were not enough, the other major producer of API’s in the world is the European Union, and due to the conflict between Russia and Ukraine, the production and distribution of some components in that continent has been interrupted as a result of sanctions or restrictions in those territories.
New challenges, new opportunities
As API production and supply is concentrated in certain regions of the world, it is imperative that drug manufacturers start looking for new options to overcome this reality, in the form of suppliers located in the same country or region.
It is also important to review the production processes of existing pharmaceutical products to determine whether they can be adapted or modified to make them more competitive in today’s demanding and changing market.
This is where options such as reducing or changing excipients or changing formulas arise. And although this decision is not easy to make from the production point of view, there are some ways that can make the change simpler.
Among the world’s most popular pharmaceutical formats are hard capsules, which are widely accepted because they are cost-efficient, easy to fill, and suitable for multiple needs. What few manufacturers are aware of is that, with the variation of liquid-filled hard capsules (LFHC), additional advantages are obtained that may be the solution to the current shortage of APIs.
The liquid-filled hard capsules were originally developed to encapsulate substances that are:
- Low melting point
- Unstable in contact with oxygen or moisture
- Poorly soluble in water
- Very high potency or requiring very low doses
This last point is of great interest, since when HPAPIs or high potency active ingredients are handled, less of these components are normally used in the manufacture of the drug, due to their high potency.
Additionally, HPAPIs are ideal to be formulated in liquid media, as this format requires fewer excipients and manufacturing steps, which is ideal in the current context of scarcity of raw materials.
Even if the drug to be manufactured does not include high potency actives, LFHC technology is also ideal, as the liquid formulation is the most bioavailable formulation available, which means that it is more easily absorbed by the body and therefore the effect of the drug is felt faster.
This, in practical terms, means that the patient may generate preference for this drug over others simply because of its rapid effect.
In conclusion
Liquid-filled hard capsules are an excellent way to circumvent the challenging circumstances of today’s pharmaceutical industry. Their advantages are not only limited to the issue of costs and raw materials, but can also generate greater consumer preference for a product in the medium and long term.
Moreover, the change in terms of production is not complex, since the same equipment used for filling hard capsules filled with dry components can be used for filling liquids, with some modifications and adjustments.
The global reality teaches us to react quickly to change and to have several options available at all times. Therefore, the success of a drug manufacturer will depend on the quality and proximity of its suppliers, as well as the ease with which it can adapt its products to new trends, or even the fact that its own products generate them.
