Fast-dissolving film with cilnidipine nanosuspension developed.
Journal name: World Journal of Pharmaceutical Research
Original article title: Development and characterization of oral fast dissolving film containing nanosuspension of cilnidipine
The WJPR includes peer-reviewed publications such as scientific research papers, reports, review articles, company news, thesis reports and case studies in areas of Biology, Pharmaceutical industries and Chemical technology while incorporating ancient fields of knowledge such combining Ayurveda with scientific data.
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Original source:
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Dharmendrasinh V. Dabhi and Dasharath M. Patel
World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: Development and characterization of oral fast dissolving film containing nanosuspension of cilnidipine
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
Doi: 10.20959/wjpr20178-9123
Download the PDF file of the original publication
Summary of article contents:
Introduction
Cilnidipine is a unique dihydropyridine calcium antagonist known for its long-lasting vasodilatory effects, but its poor solubility limits its bioavailability. To address this issue, researchers developed an oral fast-dissolving film containing a nanosuspension of Cilnidipine, aiming to enhance its dissolution and absorption. The study involved formulating and characterizing the nanosuspension, optimizing the film formation using various polymers and plasticizers, and evaluating the final product's physicomechanical properties and drug release performance. This comprehensive approach highlights the potential of advanced drug delivery systems in enhancing pharmacological effects.
Nanosuspension Development
The first critical aspect of this research was the development of the Cilnidipine nanosuspension, achieved through high-pressure homogenization (HPH). Various parameters such as homogenization pressure and stabilizer concentration (Tween 80, Poloxamer 188, and Lutrol 400) were systematically optimized to enhance the particle size reduction and improve dispersion. Using a full factorial design for optimization, the study measured responses including particle size distribution (D(90) and D(50)) and zeta potential, resulting in a stable and finely dispersed nanosuspension essential for effective film formation. The findings indicated that HPH is a viable technique for achieving the desired nanosuspension characteristics needed for further processing.
Film Formation and Evaluation
Once the optimal nanosuspension was established, the study focused on transforming it into an oral fast-dissolving film using the solvent casting method. Various film-forming polymers (HPMC E15, HEC, PVP K30, and HPMC E5) were evaluated for their compatibility and performance, with HPMC E15 selected as the optimal polymer due to its favorable physicomechanical properties. Additionally, different plasticizers (PEG 400, triethyl citrate, and glycerol) were assessed. The final formulation, utilizing HPMC E15 and triethyl citrate, demonstrated excellent properties, including enhanced folding endurance and tensile strength, while ensuring rapid drug dissolution (over 85% within 30 minutes).
In Vitro Release Studies
The in vitro release studies underscored the formulation's potential for rapid dissolution, as various batches were tested for their drug release profiles in a phosphate buffer (pH 6.8). The results showed significant differences in release rates depending on the formulation variables, confirming that the concentration of the polymer and plasticizer affected the dissolving time and overall performance of the film. The study reported that the optimized formulations exhibited rapid disintegration and dissolution, thus supporting the hypothesis that nanosuspension-loaded oral films can improve drug bioavailability and therapeutic onset.
Conclusion
This study successfully demonstrated the feasibility of creating a fast-dissolving film containing a nanosuspension of Cilnidipine through a structured design of experiments approach. By optimizing the nanosuspension and film formulation parameters, researchers enhanced the drug's solubility and bioavailability, highlighting the significant role of nanotechnology in modern pharmaceutical development. The findings advocate for further exploration of such delivery systems, potentially providing convenient and effective alternatives to traditional oral dosage forms, ultimately improving patient compliance and treatment outcomes.
FAQ section (important questions/answers):
What was the main objective of the study?
The study aimed to formulate and characterize an oral fast dissolving film containing nanosuspension of Cilnidipine for improved bioavailability and rapid drug release.
How was the Cilnidipine nanosuspension prepared?
Cilnidipine nanosuspension was prepared using high pressure homogenization, optimizing parameters such as homogenization pressure and stabilizer concentration through a factorial design approach.
What methods were used to evaluate the fast dissolving films?
The films were evaluated for thickness, folding endurance, surface pH, drug content, disintegration time, and in vitro dissolution studies using a USP type-2 apparatus.
What excipients were used in the formulation of the film?
The fast dissolving films were made using polymers like HPMC E15, HEC, PVP K30 and plasticizers such as PEG 400, Glycerol, and Triethylcitrate.
What were the results of the drug release studies?
The optimized fast dissolving films showed over 85% drug dissolution within 30 minutes, indicating effective drug release for improved bioavailability.
What was concluded about the stability of the optimized batch?
The stability study showed no significant changes in drug content and in vitro drug release over three months, confirming the formulation's stability.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “Fast-dissolving film with cilnidipine nanosuspension developed.”. This list explains important keywords that occur in this article and links it to the glossary for a better understanding of that concept in the context of Ayurveda and other topics.
1) Table:
A table presents organized data in rows and columns, making information easy to read and compare. It is essential in scientific reports to summarize experimental conditions and results, such as composition batches in the formulation of Cilnidipine nanosuspension and fast dissolving films in this study, aiding clarity in presentation.
2) Drug:
The term 'drug' refers to a chemical substance used for the diagnosis, treatment, or prevention of disease. In this study, Cilnidipine is the active drug researched for its formulation into a fast dissolving film to enhance bioavailability and patient compliance in treating certain health conditions related to hypertension.
3) Surface:
Surface in a pharmaceutical context often relates to the area of contact between substances. For example, surface properties of films impact drug release rates and stability. Measuring the surface pH of formed films is critical to ensuring they are safe and tolerable upon administration in the oral cavity.
4) Study (Studying):
A study refers to a systematic investigation to establish facts or principles regarding a subject. In this paper, various studies are conducted to formulate and characterize a nanosuspension of Cilnidipine, aiming to improve its solubility and bioavailability through innovative drug delivery mechanisms, specifically through fast dissolving films.
5) Water:
Water is a vital solvent used in pharmaceutical formulations and plays a significant role in preparing nanosuspensions. During the study, water is used to dissolve stabilizers and disperse the active drug, Cilnidipine, facilitating the production of nanosuspensions that enhance drug solubility and bioavailability.
6) India:
India denotes the geographical location where the research was conducted. The significance lies in the country's growing pharmaceutical industry, which focuses on developing innovative drug delivery systems, such as fast dissolving films containing nanosuspensions, enhancing patient adherence to treatment regimens, particularly for poorly soluble drugs like Cilnidipine.
7) Shri (Sri, Sr):
Shri is an honorific title used in India to show respect when addressing a person. In this research publication, it is used to refer to 'Shri Sarvajanik Pharmacy College,' indicating the institution's reputable status where the research was conducted, contributing to the academic and pharmaceutical development in India.
8) Transformation (Transform, Transforming):
Transformed indicates the change in state or form of a substance. In this study, it describes how the nanosuspension of Cilnidipine is transformed into a fast dissolving oral film, a method aimed at providing immediate drug release and improving patient compliance with the therapy.
9) Gujarat:
Gujarat is a state in India known for its economic growth and development in various sectors, including pharmaceuticals. The significance of mentioning Gujarat in this research relates to the regional contribution to pharmaceutical development and education, with institutions like Shri Sarvajanik Pharmacy College fostering innovative drug delivery research.
10) Glass:
Glass refers to the material used in laboratory settings for preparing and analyzing samples. In this study, glass beakers and plates are utilized during the preparation of nanosuspensions and solvent casting methods for the films, essential for creating a controlled environment and ensuring accurate measurements.
11) Reason:
Reason indicates a cause or explanation for a phenomenon or decision. In the study, reasons are provided for selected methodologies, such as high-pressure homogenization for preparing nanosuspensions, explaining why it enhances drug distribution and reduces particle size, thus improving the efficiency of the subsequent film formulations.
12) Medium:
Medium, in a pharmaceutical context, typically refers to the environment in which reactions occur or substances dissolve. Here, it denotes the use of phosphate buffer as a dissolving medium during in vitro studies, allowing researchers to evaluate the release profile of Cilnidipine from the fast dissolving films accurately.
13) Measurement:
Measurement is a systematic process of quantifying the properties of a substance. It plays a crucial role in this research as it involves measuring parameters like particle size, zeta potential, and drug release rates, which are essential for determining the efficacy and quality of the formulated Cilnidipine nanosuspension and films.
14) Discussion:
Discussion refers to the analytical discourse regarding findings and implications of the research. In this paper, the discussion section elaborates on the results obtained from the experiments conducted on Cilnidipine formulations, interpreting their significance for enhancing drug delivery systems and providing insight into future research directions.
15) Substance:
A substance is a form of matter that possesses a definite composition and properties. In the scope of this study, Cilnidipine is the primary substance investigated, focusing on its formulation characteristics and therapeutic potential when delivered via a fast dissolving film as opposed to traditional forms.
16) Relative:
Relative denotes a comparison between two or more entities. In this research, it often describes the relationship between variables, such as the effects of different concentrations of stabilizers or polymers on the performance of the fast dissolving films containing Cilnidipine, highlighting the importance of systematic evaluation.
17) Quality:
Quality refers to the standard of something regarding its ability to meet specified requirements. In the context of pharmaceutical formulations, quality assesses the efficacy and safety of drug delivery systems. The study evaluates the quality of the fast dissolving films of Cilnidipine, focusing on parameters influencing overall drug release.
18) Patel:
Patel is a common surname in India, indicating a person's professional or familial identity. In the context of this research, Dasharath M. Patel is identified as a co-author, contributing to the academic efforts in pharmaceutical research at institutions in Gujarat, enhancing collaboration among researchers in the field.
19) Pur:
Poor is a descriptor often used to characterize inadequate conditions or limited capabilities. In this study, it relates to the poor solubility properties of Cilnidipine, which the research aims to address by developing a fast dissolving film as an efficient delivery system to enhance its bioavailability and therapeutic effectiveness.
Other Science Concepts:
Discover the significance of concepts within the article: ‘Fast-dissolving film with cilnidipine nanosuspension developed.’. Further sources in the context of Science might help you critically compare this page with similair documents:
Experimental design, Particle size reduction, Accelerated stability study, Compatibility studies, Zeta potential, Dissolution rate.