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    Journal of Pharmacology and PharmacotherapeuticsNOW IN
    Article

    Formulation and Evaluation of Bosentan Monohydrate-loaded Liposome-based Dissolving Microneedle Array Patches

    Fahad Adel Balghonaim1, Kumarswamy Kunigal Chandru2, Madhu Bommanahalli Krishnegowda2, Nimbagal Raghavendra Naveen2, Prakash Goudanavar2★, Vedamurthy Joshi2, Girish Meravanige1, Predeepkumar Narayanappa Shiroorkar1, Nagaraja Sreeharsha3, Krishna Swaroop1★ Corresponding author

    1. 1Department of Biomedical Sciences, College of Medicine, King Faisal University, Al Hofuf, Al-Ahsa, SAUDI ARABIA.
    2. 2Department of Pharmaceutics, Sri Adichunchanagiri College of Pharmacy, Adichunchanagiri University, Mandya, Karnataka, INDIA.
    3. 3Department of Pharmaceutical Sciences, College of Clinical Pharmacy, King Faisal University, Al-Hofuf, Al-Ahsa, SAUDI ARABIA.

    CORRESPONDENCE

    Prakash Goudanavar

    Department of Pharmaceutics, Sri Adichunchanagiri College of Pharmacy, Adichunchanagiri University, Mandya, Karnataka, INDIA.

    pgoudanavar01@gmail.com

    Received: 03-10-2024; Accepted: 27-02-2025.

    Volume 17, Issue 1 · pp. 37–52 · PUBLISHED 2026 · DOI: 10.1177/0976500X251327444

    View on J Pharmacol. Pharmacother. original site ↗

    ABSTRACT

    Background: Pulmonary arterial hypertension is controlled by the dual endothelin receptor antagonist bosentan monohydrate. Recent advances in microneedle technology offer controlled, prolonged drug release. Objectives: This study formulated and evaluated a bosentan monohydrate-loaded liposome-based dissolved microneedles (MNs) array patch. Materials and Methods: Bosentan monohydrate liposomes were prepared using the ethanol injection method and incorporated into microneedle patches. The dissolving microneedles (DMNs) were prepared by using a two-step casting method. The first 3D computer-aided design (CAD)-designed master mold for the MNs was fabricated using SLA 3D printing and replicated using polydimethylsiloxane (PDMS). The mold was filled with a mixture of polyvinyl alcohol (PVA), polyvinylpyrrolidone (PVP-K30), PEG-400, and bosentan-loaded liposomes, then centrifuged and dried. Optimization using response surface methodology (RSM) focused on particle size, zeta potential (ZP), and entrapment efficiency (EE). Results: The optimized liposomes had an average size of 238.06 nm, a ZP of −34.33 mV, and an EE of 75.3%. Morphological analyses via microscopy and scanning electron microscopy (SEM) confirmed spherical liposomes with smooth surfaces. Drug release studies indicated a controlled release over time, reaching approximately 90% cumulative drug release (CDR) at 600 min. Kinetic modeling showed a zero-order release pattern. Mechanical testing of the MNs demonstrated a fracture point at 0.42 N, ensuring adequate strength for skin penetration. Ex vivo tests on rat skin confirmed nearly 100% penetration of the 15 × 15 microneedle array. Conclusion: The study concludes that the optimized formulation of liposomal-loaded DMNs is easy to administer, non-invasive, and biodegradable, offering a promising approach for controlled drug release in managing pulmonary hypertension (PH).

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      Balghonaim, F. A., Chandru, K. K., Krishnegowda, M. B., Naveen, N. R., Goudanavar, P., Joshi, V., Meravanige, G., Shiroorkar, P. N., Sreeharsha, N., & Swaroop, K. (2026). Formulation and Evaluation of Bosentan Monohydrate-loaded Liposome-based Dissolving Microneedle Array Patches. Journal of Pharmacology and Pharmacotherapeutics, 17(1), 37–52. https://doi.org/10.1177/0976500X251327444