1843, British scientist W. Brockedon, inspired by modern pencil manufacturing technology, invented modern tablets by pressing drug powders into molds.
1844, Irish surgeon Francis Rynd invented the world's first hollow needle, truly pioneering the history of modern injectable.
Today, the usage of oral drugs is ~62%, and the usage of injections is ~31%, together occupying ~93% of all human drugs, leaving all many other dosage forms only 7%.
In one word, they are the major methods we are using today.
1958, US Professor Alan Richard Wagner first proposed the concept of microneedle intradermal drug delivery technology. It is a revolutionary way to deliver drug candidates, via the maximum exposed surface area through the external skin route. It is painless and have minimal invasion of human organs because it will not reach anywhere deeper than human skin, so it should be a very compliant method to patients. An interesting fact is that lacking depth of needles does not mean less exposure this time while the ingredients passes through the lymphatic capillaries in the skin and eventually reach the circulatory system via human microcirculation system. Considering that all drugs are administered through the "skin" of some organs in human body (eg. gastric wall mucosa, intestinal mucosa, eye mucosa, other luminal mucosa, and surface skin), and the skin is the largest exposed organ which directly connecting the outside world, if we can achieve a painless and less invasive way through surface skin, this route should be very meaningful clinically, in order to reduce side effects (eg. gastrointestinal, first pass liver effects) and improve patient compliance.
Despite numerous scientists donated their investigations on microneedle transdermal drug delivery system (MN TDDS) since Professor Wagner, there are still a lot of CMC issues left in MN TDDS today to be challenged.
November 2020, 《Scientific American》 (an authoritative popular science magazine in US) selected 10 new technologies that are may change the world in 2020, and the MN TDDS is ranked as the 1st of all. This fully demonstrates that MN TDDS is extremely difficult, yet humans still have a strong desire and expectation to it, especially for the pharmaceutical industry.
BioQingLam is a high-tech enterprise specialized in soluble MN TDDS. We have a complete set of proprietary intellectual property rights related to MN TDDS, including but not limited to prescriptions, processes, equipment, and quality standards. We want to bring the change to the way of using drugs for all human being and have the potential to be the first one to achieve this goal with MN TDDS globally.
We have established a professional technical team in this niche field and successfully solved key CMC challenges such as drug loading, bioavailability, and content uniformity of MN TDDS.
We are oriented by delivery results and have tested our samples through animal models (such as rats, dogs, pigs, monkeys) and ultimately human studies, achieving drug delivery results that comply with regulatory requirements.
We have established small-scale and pilot scale laboratories in Shenzhen, where we have established R&D, GMP like manufacture, and quality management systems. This provided a solid technical and compliance assurance system for the development of various drugs.
We have also established an industrialization team. We have designed and constructed the world's first commercial plant for soluble MN TDDS in the Greater Bay Area of China, which is also the world's first sterile GMP plant for soluble MN TDDS. We have independently designed and developed a complete set of production equipment for this dosage form, with a batch capacity up to 100k pieces/batch. The factory is designed to meet all GMP regulatory requirements of China, US, and Europe, and supports drug research and commercial registration applications in all regulatory entities worldwide.
We have a complete set of proprietary intellectual property rights related to soluble MN TDDS technology, including prescriptions, processes, equipment, and quality standards. We also applied PCT for all of them.
We will continue our research in this field of MN TDDS technology, reform existing human drugs, and improve patients' quality of life while curing diseases.