While traditional oral pills remain a cornerstone of drug delivery due to their simplicity and familiarity, innovative drug delivery methods offer significant advantages in terms of efficacy, targeting, patient compliance, safety, and overall treatment outcomes. As technology continues to advance, these innovative methods are likely to play an increasingly important role in modern healthcare. In this blog, we aim to provide insights on the emerging trend of novel drug delivery systems. Innovative systems aim to improve the precision, convenience, and effectiveness of drug therapies, ultimately enhancing patient outcomes and quality of life.
Recent advances in the Innovative Drug Delivery Systems
Nanoparticles and Liposomes are used to enhance the delivery of drugs to specific cells or tissues, reducing side effects and improving therapeutic outcomes. Nanoparticles can be engineered to release drugs in response to specific stimuli (e.g., pH changes, temperature). Approved Products: Doxil (Doxorubicin Liposomal), Abraxane (Paclitaxel Protein-Bound Particles) used for delivery of anticancer drugs.
Transdermal Patches deliver drugs through the skin, providing a non-invasive alternative to oral or injectable routes. They are used for a variety of drugs, including pain medications, hormone therapies, and nicotine replacement. Approved Products: NicoDerm CQ (Nicotine Patch) for smoking cessation. Ortho Evra (Norelgestromin/Ethinyl Estradiol Transdermal System), a contraceptive patch that releases hormones to prevent pregnancy.
Microneedle Patches use tiny needles to painlessly penetrate the outer layer of the skin, delivering drugs directly to the bloodstream or targeting specific layers of the skin. They are being explored for vaccines, insulin, and other therapies.
Inhalable Drug Delivery method is used for respiratory diseases and systemic conditions. Inhalers and nebulizers deliver drugs directly to the lungs, providing rapid onset of action and reducing systemic side effects.
Implantable Devices provide long-term, controlled release of drugs. Examples include contraceptive implants and drug-eluting stents used in cardiovascular disease. Approved Products: Nexplanon (Etonogestrel Implant), a contraceptive implant for birth control and Gliadel Wafer (Carmustine Implant), implanted during brain surgery for releasing chemotherapy drug.
Hydrogels are networks of polymer chains that can hold a large amount of water and be used to deliver drugs in a controlled manner. They can respond to environmental stimuli, such as temperature or pH, to release drugs at the right time and place. Approved Products: ReSure Sealant - A hydrogel used to seal corneal incisions after cataract surgery.
Oral Thin Films are dissolvable films placed on the tongue that rapidly release drugs for absorption. They are convenient, especially for patients who have difficulty swallowing pills. Approved Products: Suboxone Film (Buprenorphine/Naloxone) used for opioid dependence and Zuplenz (Ondansetron) - An antiemetic oral film that dissolves on the tongue, used to prevent nausea and vomiting.
Targeted Drug Delivery: Advances in targeting mechanisms, such as monoclonal antibodies, help deliver drugs specifically to diseased cells or tissues, minimizing damage to healthy cells.
3D Printing: A novel technology allows for the creation of personalized drug delivery devices and pills with precise dosages and release profiles, tailored to individual patient needs. Approved Products: Spritam (Levetiracetam) - The first FDA-approved 3D printed drug, used to treat epilepsy.
Smart Pills are ingestible sensors that can track medication intake, monitor physiological conditions, and transmit data to healthcare providers, ensuring adherence and optimizing treatment regimens. Approved Products: Proteus Digital Health - Developed an ingestible sensor that tracks medication adherence. While not a drug delivery system per se, it is used in conjunction with medications to monitor patient compliance.
Industry Leaders in Innovative Drug Delivery Systems
Johnson & Johnson
Key Products: Duragesic (fentanyl transdermal patch), Eprex (erythropoietin injection).
Product pipeline: JNJ-4528 CAR-T therapy for multiple myeloma; Ponesimod, an oral selective sphingosine-1-phosphate receptor 1 modulator for multiple sclerosis.
Pfizer
Key Products: DepoFoam technology used in DepoCyt (cytarabine liposomal injection).
Product Pipeline: Giroctocogene fitelparvovec (SB-525), Gene therapy for hemophilia A.
AbbVie
Key Products: Humira (adalimumab), an injectable biologic for autoimmune diseases, and its auto-injector devices.
Product Pipeline: ABBV-3373, TNF inhibitor antibody-drug conjugate for rheumatoid arthritis.
Roche
Key Products: Kadcyla (ado-trastuzumab emtansine), an antibody drug conjugate (ADC) for HER2-positive breast cancer.
Pipeline Products: Polivy (polatuzumab vedotin): ADC for lymphoma.
Novartis
Key Products: TOBI Podhaler (tobramycin inhalation powder), Kymriah (tisagenlecleucel), a CAR-T cell therapy.
Pipeline Products: Zolgensma (onasemnogene abeparvovec): Gene therapy for spinal muscular atrophy; Iptacopan (LNP023): Oral small molecule for rare kidney diseases.
Merck & Co.
Key Products: Implanon/Nexplanon (etonogestrel implant), Januvia (sitagliptin) with innovative tablet formulations.
Pipeline Products: V920 (rVSV-ZEBOV): Ebola virus vaccine using a novel delivery platform; MK-8591 (islatravir): Once-monthly oral therapy for HIV.
AstraZeneca
Key Products: Symbicort (budesonide/formoterol) inhaler, Faslodex (fulvestrant) injectable.
Sanofi
Key Products: Lantus (insulin glargine) SoloStar pen, Praluent (alirocumab) auto-injector.
GlaxoSmithKline (GSK)
Key Products: Advair Diskus (fluticasone/salmeterol) inhaler, Shingrix (zoster vaccine recombinant).
Regulations on the Innovative drug delivery system
Regulations on drug delivery systems are critical to ensure their safety, efficacy, and quality. These devices are regulated in a similar manner as medical devices and have to been classified based on the risk they pose.
An overview of the key regulatory frameworks and requirements for drug delivery devices:
Unites States Food and Drug Administration (FDA)
Classification: Devices are classified into Class I, II, or III based on risk.
Premarket Notification (510(k)): For most Class II devices. Manufacturers must demonstrate that their device is substantially equivalent to a legally marketed device.
Premarket Approval (PMA): Required for most Class III devices. It involves a rigorous process of demonstrating safety and effectiveness through clinical trials.
Investigational Device Exemption (IDE): Allows a device to be used in a clinical study to collect safety and effectiveness data.
In 2022, FDA had granted permission under (510(k)) to commercialize Biocorp’s Mallya smart medical device, which links insulin pens.
European Medicines Agency (EMA)
Medical Device Regulation (EU MDR): Provides a comprehensive regulatory framework for medical devices, including drug delivery devices.
CE Marking: Indicates that a device meets EU safety, health, and environmental protection requirements. Requires conformity assessment by a Notified Body.
Clinical Evaluation: Must demonstrate that the device achieves its intended purpose without posing unacceptable risks.
Post-Market Surveillance: Ongoing monitoring of device performance and safety once it is on the market.
Unique Device Identification (UDI): Enhances the traceability of devices.
Japan (PMDA)
Pharmaceuticals and Medical Devices Agency (PMDA)
Classification: Similar to FDA, with Class I (low-risk) to Class IV (high-risk).
Approval Process: Involves rigorous review of clinical data, manufacturing processes, and quality management systems.
GMP and QMS: Manufacturers must comply with Good Manufacturing Practice (GMP) and Quality Management System (QMS) standards.
Post-Market Surveillance: Required to monitor the safety and effectiveness of the device after it is marketed.
International Organization for Standardization (ISO)
ISO 13485: Specifies requirements for a quality management system for medical devices.
ISO 14971: Provides a framework for risk management in medical devices.
ISO 10993: Focuses on the biological evaluation of medical devices to ensure biocompatibility.
Innovative drug delivery methods offer several advantages over traditional oral pills, addressing some of the limitations and challenges associated with conventional oral administration. These drug delivery systems demonstrate the significant advancements in pharmaceutical technology, providing more effective, safer, and patient-friendly treatment options. As research and development continue, we can expect to see more innovative solutions emerging in the field of drug delivery. Strict regulations ensure that drug delivery devices are safe for public health and fostering innovation in medical technology.
Discover the cutting-edge solutions and unparalleled expertise that Artixio brings to the table. Artixio is your partner in progress for all your regulatory needs. Contact Artixio at info@artixio.com today.
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