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Development and In Vivo Evaluation of a Novel Vitamin D3 Oral Spray Delivery System
Xin Yan1, Enhao Lu1, Zhuo Song2
1Key Laboratory of Smart Drug Delivery, Ministry of Education, School of Pharmacy, Fudan University, Shanghai 201203, China.
Abstract:
Developing drugs that are highly selective to host tissues but are the least toxic remains one of the most difficult challenges in cancer treatment. Recent studies have shown that tumor cells from a variety of sources can express vitamin D3 receptors and that the response to vitamin D3 and its analogs is prone to growth arrest and cell death. However, conventional vitamin D3 drug formulations lack dose control and cannot target specific cells or tissues. The aim of this study was to prepare vitamin D3 nanospray for inhalation delivery route. This study evaluated the physical properties of the formulation (particle size distribution and biological stability), the total number of sprays per bottle, the spray volume per spray, and the loading variance of the spray. The optimized vitamin D3 spray formula is easy to spray, has fewer drips, and has a fast drying time. It can be stored for 3 months at 37 ± 2 °C temperature, 75 ± 5% relative humidity, and away from light, and can maintain biological stability. This study showed that compared with traditional nasal sprays, the spray has a larger fan angle (82.1 degrees) and beam width (104.88 mm), more symmetrical spray on both sides of the spray column, a faster coverage of the administration site, and a wider range, which is suitable for inhalation delivery routes.
Insights
This study developed a novel vitamin D3 nanospray for targeted cancer treatment via inhalation. The optimized formulation offers improved delivery and stability, addressing limitations of conventional vitamin D3 therapies.
Area of Science:
- Oncology
- Nanotechnology
- Drug Delivery
Background:
- Developing selective and low-toxicity cancer therapeutics is challenging.
- Tumor cells express vitamin D3 receptors, responding to vitamin D3 with growth arrest and cell death.
- Conventional vitamin D3 formulations lack dose control and targeted delivery.
Purpose of the Study:
- To prepare a vitamin D3 nanospray for inhalation delivery.
- To evaluate the physical properties and biological stability of the nanospray formulation.
- To assess the suitability of the nanospray for inhalation routes.
Main Methods:
- Formulation of vitamin D3 nanospray for inhalation.
- Evaluation of particle size distribution and biological stability.
- Assessment of spray characteristics including volume, variance, fan angle, and beam width.
Main Results:
- The optimized vitamin D3 spray demonstrated ease of use, minimal dripping, and rapid drying.
- The formulation maintained biological stability for 3 months under specified storage conditions.
- The nanospray exhibited superior spray characteristics (larger fan angle, wider beam width, symmetry) compared to traditional nasal sprays.
Conclusions:
- Vitamin D3 nanospray is a promising formulation for inhalation delivery in cancer treatment.
- The developed nanospray overcomes limitations of conventional vitamin D3 delivery methods.
- The formulation's enhanced physical and spray properties make it suitable for targeted drug delivery via inhalation.
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