PharmaTher's Preclinical Trial For Ketamine Micro-Needle Patch Shows Positive Results For Dosing

Ketamine-producer PharmaTher Holdings Ltd. PHRRF has successfully completed research evaluating its patented hydrogel-forming microneedle patch, PHARMAPATCH, to deliver ketamine and KETABET (ketamine and betaine anhydrous). 

The combination aims to study the possibility of preventing potential side effects of repeated ketamine treatment for depression and other indications (such as suicidal ideation, substance abuse, PTSD, neurological disorders and chronic pain), by studying the potential of desired dosage forms and pharmacokinetic profiles.

The company will next engage in preclinical studies to demonstrate delivery, dosing and safety profiles of ketamine in a comparable animal model to support regulatory filings to eventually conduct human clinical studies in Q4-2022 for treatment-resistant depression and pain.

Proprietary And Study Details

PharmaTher’s microneedle patch has proven to successfully deliver the dissociative hallucinogen esketamine, which may overcome the drawbacks associated with ketamine administration in an intravenous or nasal spray format. 

Led by Prof. Ryan Donnelly at Queens University Belfast, the study sought to develop and characterize PHARMAPATCH for sustained and safe transdermal delivery of ketamine and KETABET and closing production scale-up processes for clinical tests. 

The in vitro technique was used for the characterization of drug recovery and stability before drug permeation from films via hydrogel-forming microneedle array patches. Based on those findings, lead patches formulations were selected for in vivo testing on rats to assess their ability to achieve sustained plasma concentrations of ketamine and betaine within the therapeutic range for potential antidepressant therapy over the course of 48 hours.

The hydrogel-forming patch-mediated delivery of ketamine and betaine were compared with intramuscular injection and orally administered solution. 

Ultimately, blood sample results showed that PHARMAPATCH was able to deliver plasma levels of ketamine (between 70-200 ng/mL) in a controlled manner throughout the study.

This delivery system’s high degree of flexibility would supply effective treatment regimens beyond 48 hours, with further alterations in surface area, application time, and drug loading of the patches.

More On Microneedle Intradermal Drug Delivery

The method provides an efficient and painless way of increasing the skin permeation of many drugs, including ketamine. 

PharmaTher‘s current ketamine approach consists of a drug reservoir placed on top of the hydrogel microneedle array. After administration into the skin, the microneedles become hydrated and swell, creating pores for the reservoir to release the drug into the tissue over the treatment course. 

As shown by studies, the transdermal delivery provides drug concentrations in the system within minutes after administration and is maintained over multiple days. 

A highlight offered by this administration system is that it includes patients with pre-existing conditions that keep them from oral or inhalation dosing. 

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