Non-Pressurized Topical Spray Pharmaceutical-Methodology of Formulation Development and Quality Control Management

  • Neelam Pawar Department of Pharmaceutical Sciences, Baba Mastnath University, Asthal Bohar, Rohtak, Haryana, INDIA.
  • Pawan Jalwal Department of Pharmaceutical Sciences, Baba Mastnath University, Asthal Bohar, Rohtak, Haryana, INDIA.
Keywords: Non-pressurized topical spray, Lifecycle management, Scale up and post approval changes, Quality control, Valve Components

Abstract

The medicine was given to the target site with a pressurized topical spray (aerosol pharmaceutical) and a non-pressurized topical spray solution by gently pressing the spray container against the skin and initiating the spray. Formulation components consists of product concentrate (one or more pharmaceutical drugs with relevant excipient) and packaging components (valves, pump, actuator, container). After formulation process development various quality control test like spray pattern, spray content uniformity and geometry, particulate matter, droplet size distribution, microbial limit, net content, pH, osmolarity, weight loss, leachability, viscosity, valves, actuators, diptubes, weight checking, leak test, valve discharge rate, dosage with valves, therapeutic activity, and toxicity studies to check the quality and efficacy. The benefit of Topical Spray Life Cycle Management (post-approval adjustments, 30-day supplements, annual report, Food and Drug Administration inspection and enforcement, cover letter, risk management standard and related information from the International Organization for Standardization) is that it covers the entire lifecycle of a topical spray, from conception through formulation design development to marketing. The product lifecycle management data offers regulatory bodies with a significant financial benefit. Topical non-pressurized sprays have been developed for a variety of applications due to their ease of use, environmental friendliness, low cost, and innovative technology. This review give details about meter dose topical spray of Estradiol, 1% tolnaftate, 2% Miconazole nitrate spray, 0.5% w/w Voriconazole spray, Clotrimazole transdermal apray, Lopinavir meter dose transdermal spray are studied by researcher. This review also enlisted patents and marketed formulation on topical spray from year 2007 to 2020.

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Published
2021-10-13
How to Cite
1.
Pawar N, Jalwal P. Non-Pressurized Topical Spray Pharmaceutical-Methodology of Formulation Development and Quality Control Management. ijpi [Internet]. 13Oct.2021 [cited 16Oct.2021];11(3):260-8. Available from: http://www.jpionline.org/index.php/ijpi/article/view/1089