California Patent of the Month – June 2023
Rani Therapeutics, LLC was founded with a specific mission in mind. The company is set on improving the lives of patients by replacing injections with oral pills. Millions of people endure painful and inconvenient injections to treat their chronic conditions. This has been the standard method as the pharmaceutical industry has failed to deliver a biologic that doesn’t get digested in the GI tract.
Complications such as gastric irritation, breakdown of the drug compounds in the stomach, and poor absorption have hindered the effectiveness of these drugs. Conventional alternatives like intravenous and intramuscular delivery methods also come with their drawbacks. This has led to the need for an improved drug delivery method that addresses these limitations and provides better outcomes for patients.
In line with their mission, Rani Therapeutics has recently patented their method of preparing pharmaceuticals which support oral delivery – without digestion or gastric irritation. Their methods prepare biologics to be delivered directly into the patient’s lumen – a section of the intestinal tract. The pill moves through the stomach, where acids typically break down drugs, remaining intact until it reaches the intestine, where the drug is then delivered into the intestinal wall. The highly vascularized intestinal wall allows the drug to be absorbed rapidly.
The pill is designed with an actuator which improves alignment and maximizes drug delivery efficiency. This actuator responds to conditions in the small intestine, such as pH, to initiate drug delivery. Upon reaching the small intestine, the device releases a therapeutic agent preparation into the intestinal wall using tissue-penetrating members. These members, equipped with drug-loaded needles or darts, penetrate the wall and deliver the therapeutic agent directly into the bloodstream. This targeted approach significantly reduces the time required to achieve the maximum concentration of the drug in the body compared to non-vascular injections. Since the intestinal wall has no sharp pain receptors, these injections impart no pain.
Furthermore, Rani Therapeutics’ swallowable devices offer the advantage of delivering drugs that were previously only administered through intravenous or other non-oral methods. By delivering drugs directly to the intestinal wall, these devices enable a more efficient and effective absorption of poorly absorbed or poorly tolerated drugs, opening new possibilities for their application in various medical conditions.
The materials used in the device are carefully selected to ensure safe degradation within the gastrointestinal tract. Biodegradable components, such as tissue-penetrating members and capsule seams, allow for controlled device degradation and eventual excretion, minimizing the risk of device retention in the GI tract.
Rani Therapeutics’ swallowable drug delivery devices hold great promise for the future of medical treatment. With their ability to enhance drug absorption, reduce administration time, and expand the range of drugs that can be administered orally, these devices have the potential to revolutionize therapeutic approaches across a wide range of diseases and conditions.
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