Novo estudo clínico valida o CBtru® da dsm-firmenich como um caminho promissor para terapias à base de CBD amigáveis ao paciente

dsm-firmenich, a leading innovator in health, nutrition, and beauty, today reveals new clinical data confirming that the bioavailability of cannabidiol (CBD)-based therapies can be enhanced in oral solid dosage forms. The clinical trial results demonstrated that dsm-firmenich’s CBD drug product intermediate, CBtru®, is absorbed into the bloodstream at a similar level compared to Epidiolex®, the first (and to this date only) commercially approved CBD drug product on the market, which is in a liquid oil-based dosage form. This is the first time that a solid CBD formulation has shown comparable absorption results to the liquid oil-based reference product. With this evidence, CBtru® presents a new opportunity for pharmaceutical companies to develop solid oral CBD-based therapies, offering patients a more convenient and user-friendly alternative to current oil-based medicines

Como o CBtru® pode moldar o futuro da medicina moderna

  Research in the CBD field has already led to the launch of the oil-based drug product Epidiolex®, for the management of treatment-resistant epileptic syndromes. Despite these advances, current oil-based CBD formulations might present notable challenges for patients, including difficulties with accurate dosing and sensory hurdles. Progressing CBD clinical development towards more patient-friendly solid oral dosage forms is key for expanding treatment options and patient convenience. However, these advancements have been restricted by the limited solubility and variable bioavailability of CBD, which can be as low as 6% due to incomplete absorption in the gut and significant pre-systemic elimination in the liver.¹ The solubility and absorption of CBD generally increases when co-administered with a high-fat meal, because lipophilic molecules can dissolve in the fat content of food. As individuals have different diets and mealtimes, this leads to considerable

Estudo revela: CBtru® iguala a biodisponibilidade do CBD à base de óleo

To validate the enhanced bioavailability of dsm-firmenich’s proprietary CBD drug product intermediate for use in solid oral dosage forms, a clinical study (NCT06578455) set out to investigate the absorption and pharmacokinetic profile of CBtru® compared to the market-approved reference drug product Epidiolex®, a liquid sesame oil-based formulation of CBD. The randomized cross-over study was conducted in 32 healthy subjects, half of them men and half of them women, aged between 19 and 55. The study design involved four treatment phases, with each participant receiving both CBtru® and Epidiolex® under fed and fasted conditions, separated by a washout period of two weeks every time. The dose level was 400 mg CBD, where CBtru® was administered in capsules, while the oil-based reference product was given using a syringe. The plasma concentration of CBD was analyzed over 24 hours post treatment, revealing that the bioavailability of CBtru® was as good

Expansão das opções de tratamento à base de CBD para pacientes

"Essas descobertas representam um avanço significativo no espaço do CBD - e no mercado farmacêutico mais amplo", explica a Dra. Zdravka Misic, Diretora Associada de Inovação Farmacêutica da dsm-firmenich. "Com os dados indicando que o CBtru® é pelo menos tão biodisponível quanto o produto de referência à base de óleo líquido líder de mercado, abrimos novos caminhos para o desenvolvimento de terapias à base de CBD usando formas de dosagem oral sólidas. Isso é realmente inovador, pois abre caminho para sistemas de entrega mais amigáveis ao paciente, como comprimidos ou cápsulas. Essas formas de dosagem ajudam a aumentar a eficácia e, ao mesmo tempo, aumentam a conveniência e a conformidade do paciente. Além disso, além de melhorar a experiência do paciente, esse avanço pode acelerar a pesquisa em áreas terapêuticas em que o CBD demonstrou potencial, como controle da dor, inflamação, câncer, diabetes, bem como distúrbios do sono, do humor e psicóticos."

Para obter mais informações sobre o CBtru®, acesse aqui.

Sobre a dsm-firmenich

Como inovadores em nutrição, saúde e beleza, dsm-firmenich reinventa, fabrica e combina nutrientes vitais, sabores e fragrâncias para que a crescente população mundial prospere. Com nossa ampla gama de soluções, com ingredientes naturais e renováveis e renomadas capacidades de ciência e tecnologia, trabalhamos para criar o que é essencial para a vida, desejável para os consumidores e mais sustentável para o planeta. A dsm-firmenich é uma empresa suíço-holandesa, listada na Euronext Amsterdam, com operações em quase 60 países e receitas de mais de € 12 bilhões. Com uma equipe diversificada e mundial de quase 30.000 funcionários, trazemos o progresso à vida™ todos os dias, em todos os lugares, para bilhões de pessoas.