Mohd. Wasiullah,
Piyush Yadav,
Prakriti Maurya,
Tasin Ansari,
- Principal, Dept. of Pharmacy, Prasad Institute of Technology, Jaunpur, Uttar Pradesh, India
- Professor &Head, Department of Pharmaceutical Chemistry, Prasad Institute of Technology, Uttar Pradesh, India
- Lecturer, Dept. of Pharmacy, Prasad Institute of Technology, Jaunpur, Uttar Pradesh, India
- Research Scholar, Dept. of Pharmacy, Prasad Institute of Technology, Jaunpur, Uttar Pradesh, India
Abstract
Acebrophylline, a commonly utilized bronchodilator with anti-inflammatory properties, has become a key therapeutic option for managing respiratory conditions like asthma, chronic obstructive pulmonary disease (COPD), and chronic bronchitis. This review explores the journey of Acebrophylline from its clinic formulation to its development and commercialization, focusing on the key aspects of formulation strategies, pharmacological properties, and regulatory considerations. The drug’s dual mechanism of action, which involves both bronchodilation and anti-inflammatory effects, offers an advantage in treating obstructive airway diseases. This article discusses the challenges in formulating Acebrophylline, including issues related to solubility, stability, and bioavailability enhancement, as well as the strategies employed to address these challenges through advanced drug delivery systems, such as oral formulations, inhalation devices, and extended-release technologies. Additionally, we review the clinical trial data, regulatory processes, and post-marketing surveillance that have ensured its safety and efficacy in treating patients. Despite the successes, the review highlights ongoing challenges in formulation, patient compliance, and market competition.
Keywords: Drug Discovery, Respiratory disease, Chronic obstructive pulmonary disease (COPD), Pharmacokinetic, Pharmacodynamic, Asthma treatment
[This article belongs to Research & Reviews: A Journal of Pharmacology (rrjop)]
Mohd. Wasiullah, Piyush Yadav, Prakriti Maurya, Tasin Ansari. From Clinic Formulation to Development of Acebrophylline. Research & Reviews: A Journal of Pharmacology. 2025; 15(01):1-14.
Mohd. Wasiullah, Piyush Yadav, Prakriti Maurya, Tasin Ansari. From Clinic Formulation to Development of Acebrophylline. Research & Reviews: A Journal of Pharmacology. 2025; 15(01):1-14. Available from: https://journals.stmjournals.com/rrjop/article=2025/view=194220
Full Text PDF
References
- Kashid AM, Khilare AC, Sable SB. Stability indicating HPTLC method development and validation for acebrophylline in bulk and its tablet dosage form. Asian Journal of Pharmaceutical Analysis. 2023;13(4):255-60. 52711/2231-5675.2023.00042
- Luo MX, Hua S, Shang QY. Application of nanotechnology in drug delivery systems for respiratory diseases. Molecular Medicine Reports. 2021 May 1;23(5):1-7. https://doi.org/10.3892/mmr.2021.11964
- Bruzell EM, Granum B, Hetland RB, Husøy T, Rohloff J, Wicklund T, Steffensen IL. Risk assessment of other substances–Curcumin. Opinion of the Panel on Food Additives, Flavourings, Processing Aids, Materials in Contact with Food and Cosmetics of the Norwegian Scientific Committee for Food Safety. VKM Report. 2016.
- Pozzi E. Acebrophylline: an airway mucoregulator and anti-inflammatory agent. Monaldi Archives for Chest Disease. 2007;67(2). https://doi.org/10.4081/monaldi.2007.498
- Tapadar SR, Das M, Chaudhuri AD, Basak S, Mahapatra AB. The Effect of Acebrophylline vs Sustained Release Theophylline in Patients of COPD- A Comparative Study. J Clin Diagn Res. 2014 Sep;8(9):MC11-4. doi: 10.7860/JCDR/2014/8176.4869.
- De Rubis G. Development of Advanced Drug Delivery Systems for Respiratory Diseases. University of Technology Sydney (Australia); 2023. . Journal of Pulmonary Medicine, 22(4), 281-289.
- Shah, N., Sheikh, A. and Jain, H. (2021) “Formulation Development and Optimization of Sustained Release Microspheres of Acebrophylline”, Journal of Pharmaceutical Research International, 33(33A), pp. 13–28. doi: 10.9734/jpri/2021/v33i33A31767.
- Bauskar MD, Nandedkar SY, Wagh RD. Formulation design and optimization of pulsatile release tablet of acebrophylline with swelling and erodiable layers for treatment of nocturnal bronchial asthma. International Journal of Pharmaceutical Sciences and Research. 2011 Dec 1;2(12):3100-08.
- Dhaneshwar SR, Jagtap VN. Development and Validation of Stability Indicating RP-HPLC-PDA Method for Determination of Acebrophylline and It’s Application for Formulation Analysis and Dissolution Study. J Basic and App Sci Research. 2011;1(11):1884-90.
- Pozzi E. Acebrophylline: an airway mucoregulator and anti-inflammatory agent. Monaldi Arch Chest Dis. 2007 Jun;67(2):106-15. doi: 10.4081/monaldi.2007.498.
- Krishna, N H; Nene, Amita,; Modi, Mahavir; Reza, Tanvir; Songara, Ashwin Deshmukh, Vikrant5. Expert opinion on montelukast and acebrophylline combination in the management of asthma. Indian Journal of Allergy, Asthma and Immunology 35(2):p 48-54, Jul–Dec 2021. | DOI: 10.4103/ijaai.ijaai_4_22
- Weinberger M. The pharmacology and therapeutic use of theophylline. Journal of allergy and clinical immunology. 1984 May 1;73(5):525-40.
Research and Reviews: A Journal of Pharmacology
Volume | 15 |
Issue | 01 |
Received | 14/12/2024 |
Accepted | 06/01/2025 |
Published | 15/01/2025 |