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IFIIP GmbH as "Institute for innovation in industrial pharmacy" is dedicated to boost innovation in the industrial environment. This dedication is not an easy task due to the high density of regulations in the pharmaceutical industry.

It is evident, that FDA and EMEA are aware, that the high density of regulations are not favorable for innovations. This fact prompted the PAT and QbD initiative. Some of the "Killing Phrases" for e.g. an innovative new process has been: "Is your new process accepted by FDA?" or "Do you have large scale equipment to manufacture your new drug delivery system in a real GMP environment?"

Probably in a similar context Niccolo Macchiavelli (1469-1527) made the following statement:"The Innovator has for enemies all, who have done well under the old law".

On the other hand the innovation is the motor of a prosperous economy. Only the innovation can boost the market, independent of the type of innovation:

Already a relatively minor or incremental innovation may have an important impact on the sales of the product. Such a nice example is known to IFIIP GmbH: A generic company has copied the product of the originator, a suspension of an antibiotic for pediatric use. The only difference between the generic and the originator product was the better taste of the generic, which has lead to much better sales of the generic product.

It is evident, that an incremental innovation is not based on a breakthrough in science, but can be very beneficial for the further economic development of a company.

Personalized medicine (PM) is a real scientific breakthrough, but as PM takes care only of a subpopulation with the corresponding genome features, the potential to become a blockbuster product is limited.

Innovative dosage forms such as Transdermal Therapeutic Systems (TTS) and osmotic drug dosage forms (OROS) had only a limited success and did not fulfill the initial expectations (see e.g. Moderne Arzneiformen, SWISS PHARMA 6/85).

Solid dosage forms have the highest share of all dosage forms due to its convenience of administration. In case of a short biological half life of the active drug substance it is mandatory to develop and to market a controlled release formulation in order to improve patient compliance.

Patient compliance is an important issue concerning health care costs: insufficient patient compliance creates follow-up health problems and in severe cases a hospitalization.

A new therapeutic entity (NTE), i.e. a new chemical entity (NCE) and / or new biological entity, introducing a new type of therapy has the top position in the rank order of pharmaceutical innovations.

Unfortunately the introduction of a new therapeutic entity is extremely costly and the number of NTEs registered in the past decade has declined. To improve such a situation it is important to reduce the R&D costs. In this respect PricewaterhouseCoopers, PwC, suggests to invest in the concept of PHARMA 2020 , see: www.pwc.com.au/industry/healthcare/.../Pharma2020Vision_May07.pdf.

Close to the top position of new pharmaceutical innovations is a new indication of an existing drug. Such a discovery can be an extremely fruitful contribution to the society and has to be considered as a very important innovation.

Any new analytical or other technology, which can reduce the time to market such as a computer assisted formulation design has the potential of an important innovation with respect to implement the PwC concept of PHARMA 2020 (see ppt/pdf- presentations, tutorials).

A new process technology, which shows an advantage compared to an existing technology, may replace an existing technology. In the pharmaceutical industry the batch-type manufacturing process is the golden standard. A successful change to a continuous or semi-continuous production process can avoid classical scale-up problems (see ppt/pdf- presentations, tutorials).

Due to the difficult freezing step, the conventional freeze drying process has an intrinsic problem and does not correspond to a six –sigma performance with a zero defective production. A novel spray-freeze drying process has the potential to become a disruptive technology, i.e. could replace all classical freeze dryers ( see ppt/pdf-presentations, tutorials). The latter technology is of special importance in case of biological and low water soluble classical drugs.

Liquid dosage forms play an important role in case of biological drugs. There is a great potential for innovations, however it will be important to take into account percolation theory and the internal structure of liquids (see ppt/pdf presentations/tutorials).

Product life cycle management of existing drugs needs as a prerequisite an innovation to be able to extent patent protection.

The number of excipients and drug carriers as an aid for the formulation of dosage forms is very limited.

An important innovation in the area of excipients are mucoadhesive polymers, which may include as an additional function the property of a drug absorption enhancer ( see e.g. ThioMatrix Polymers).

A new, multi-functional (filler, binder,disintegrant) single component excipient is MCC Sanaq BURST, a new type of Microcrystalline Cellulose, marketed by Pharmatrans Sanaq, Basel ( see ppt presentations). This new excipient can be used for the formulation of Oral Dispersable Tablets or can be used to repair formulations, being out of specifications (OOS) due to a too long disintegration time and /or a problem with a slowing down of the dissolution rate profile. It is also possible to manufacture fast disintegrating pellets (see ppt/pdf-file).

There is a trend from single excipients towards drug carrier systems, such as pellet formulations based on neutral (e.g. Cellets, sugar spheres, Mannitol pellets) or functional pellets such as TAP (Tartaric Acid Pellets).

As really new single component excipients are very rare, some companies are manufacturing "combination excipients" facilitating the task of the formulator. The innovation is in this case again an incremental one, however it can be described as a facilitator for the formulators, speeding –up the process of time to market. If the innovation is considered to contribute to a better convenience the goal of the inventor has been achieved.

Concerning the administration of medicinal products, such as tablets, capsules etc a better convenience may be mandatory to increase patient compliance!

Due to the demographic development of the population with a higher and higher proportion of elderly patients suffering at the same time from different diseases combination drugs can be the only answer.

Combination drugs are able to increase patient compliance and contribute to the convenience of administration in homes for elderly people etc.

Combination drugs can be developed relatively fast, if Virtual R&D reality is implemented, using F-CAD (Formulation - Computer-Aided Design, provided by CINCAP GmbH, is applied and if the drug-excipient compatibility is known. If the drug – excipient compatibility is not known, IFIIP GmbH and CINCAP GmbH suggest to use the services of RPD tool GmbH (Rapid Pharma Development tool, Birsfelden, Switzerland).

Due to the fact, that F-CAD of CINCAP can develop a combination of drugs , which are off-patent, very fast and in a very efficient way to have the required dissolution profiles of the individual drug component, the time to market can be reduced in an impressive way (see ppt/pdf- presentations, tutorials).

F-CAD of CINCAP GmbH is able to replace very efficiently the work in the lab by computer work. Thus only a limited number of experiments in the galenical lab are necessary to validate the in-silico experiments achieved with the computer.

Thanks to the emerging field of Artificial Intelligence,, the digitalization and computational science  a new research initiative is needed of the format of the  US Nano Initiative in 1999, see  www.ifiip.ch /articles download publication  Hans Leuenberger, “What is Life ?“ in SWISS  PHARMA  40 years, 2019-1

In the classical laboratory in the pharmaceutical industry the "80%/20%" working rule is applied, which intrinsically leads to a ca. 2-sigma value of quality performance In case of F-CAD of CINCAP GmbH it is possible to achieve a "100%/10%" rule, i.e. that a 6-Sigma Performance (Zero defect Manufactruing capability) can be realized using only half of the laboratory resources (see ppt/pdf-presentations/tutorials).

Due to the facilitated prototyping of dosage forms using F-CAD, similar savings like in the aircraft industry concerning the in-silico designing and testing of the airbus 380, resp. Boeing 777 can be expected (see ppt/pdf- presentations, tutorials).

In order to reduce health care costs in Europe, the United States and Japan due to the increasing number of elderly patients, cheap combination drugs of originator and/or generic blockbuster drugs will be important.

In case of the BRIC and other countries it will be of special interest to use F-CAD for a save and fast introduction of important generic drugs, which fulfill the essential needs of their health care system and concerning the modernization of their pharmaceutical industry. Combination drugs should be also affordable due to the application of F-CAD.

Combination drugs of genuine blockbusters have the potential to become a new blockbuster product and to reduce health care costs in the elderly population.

Last , but not least some final comments:

The creation of innovations can be boosted by promoting trans–disciplinary research groups, where different core competences overlap and fertilize each other. This is also the goal of the US National Nano Initiative, NNI (see e.g. http:// www.wtec.org/loyola/nano/IWGN Research Directions/) to contribute to the economic growth by innovations.

Nanoscience and Nanotechnology require a convergence of the classical disciplines biology, chemistry and physics to become successful. Nanobiosciences (see Annual Report 2000) will play an important role.for the successful development of life science.

The application of percolation theory in life sciences will be essential: The conjecture, that life can only exist in three dimensions can be easily verified by the fact, that fortunately in three dimensions two percolation thresholds exist.

These two thresholds can act as a natural , physiological switch to go from the pure state A to the pure state B including an intermediate transitional state A-B, respectively B-A and vice-versa. Interestingly, it is necessary to use numerical methods to calculate in three dimensions percolation thresholds, e.g. with Cellular Automata software.

Life sciences has the potential to achieve scientific breakthroughs creating innovative pharmaceutical products as spin-offs thanks to the new research area of Systems-Biology.In this context advanced computational science with the application of Virtual R&D Reality will play a major role especially the use of a "first principle approach" based on Cellular Automata software (see also: www.wolframscience.com, Stephen Wolfram "A New Kind of Science", Princeton University).

Last Updated on Wednesday, 13 March 2019 13:21