Mouth dissolving tablet formulation and evaluation of bambuterol HCl
Journal name: World Journal of Pharmaceutical Research
Original article title: Formulation and evaluation of mouth dissolving tablet of bambuterol hydrochloride
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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Nayan N. Vadsola and Bijal Prajapati
World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: Formulation and evaluation of mouth dissolving tablet of bambuterol hydrochloride
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
Doi: 10.20959/wjpr201611-6247
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Summary of article contents:
Introduction
The study focuses on the formulation and evaluation of mouth dissolving tablets (MDTs) containing Bambuterol Hydrochloride, an antiasthmatic drug aimed at improving disintegration time and drug release percentage. The incorporation of Camphor, a subliming agent, along with Sodium deoxycholate and Cross povidone as a permeation enhancer and a super-disintegrant, respectively, was key in optimizing tablet performance. By employing a 3² full factorial design, the researchers evaluated various formulations and their respective properties through in vitro and ex vivo testing, ultimately seeking to enhance the bioavailability of the drug.
Importance of Mouth Dissolving Tablets
Mouth dissolving tablets are defined as solid dosage forms that rapidly disintegrate when placed on the tongue, not requiring water for administration. According to the European Pharmacopoeia, these tablets should dissolve within three minutes. The study emphasizes the significance of MDTs for patients, particularly children and the elderly, who may have difficulty swallowing conventional tablets. The formulation of Bambuterol Hydrochloride in this form aims to deliver faster onset of action and enhance patient compliance.
Optimization of Formulation
The optimization of the MDT formulation was carried out using a design of experiments approach, specifically a 3² full factorial design. Independent variables included the concentrations of Camphor and Sodium deoxycholate. The dependent variables analyzed were the percentage of in vitro drug release and ex vivo permeation. The study revealed that increasing the concentrations of these components significantly enhances drug release, with the optimized formulation (B9) demonstrating a drug release of 90% and ex vivo permeation of 78.46% within ten minutes. This outcome indicates the effectiveness of using a statistical approach to formulation development.
Evaluation of Stability
The stability of the optimized formulation (Batch B9) was analyzed under different conditions over one month. Results indicated that the tablets maintained their potency, with no significant changes in drug release and permeation under both room and accelerated conditions (40°C, 75% RH). This stability suggests that the formulation is reliable for long-term storage and use, bolstering the prospect of its application in clinical settings.
Conclusion
The study successfully formulated and evaluated a mouth dissolving tablet of Bambuterol Hydrochloride utilizing a combination of sublimable agents and permeation enhancers. The findings underline the potential of this formulation to significantly improve the drug's bioavailability and patient compliance compared to traditional dosage forms. The optimized formulation demonstrated robust stability and effective drug release characteristics, presenting itself as a promising alternative for the delivery of antiasthmatic medication, particularly for pediatric patients. Further research may focus on validating these formulations in real-world clinical scenarios to ascertain their efficacy and practicality.
FAQ section (important questions/answers):
What is the main purpose of this study involving Bambuterol Hydrochloride?
The study aims to formulate and evaluate a mouth dissolving tablet of Bambuterol Hydrochloride to reduce disintegration time and enhance drug release, facilitating better management of asthma.
What excipients were used in the formulation of mouth dissolving tablets?
The formulation used Camphor as a subliming agent, Sodium deoxycholate as a permeation enhancer, and Crospovidone as a super-disintegrant, among others, to improve tablet characteristics.
What method was used for the preparation of Bambuterol tablet?
The tablets were prepared using the sublimation method, mixing all ingredients and compressing them into tablets, followed by placing them in a vacuum oven to achieve the desired properties.
How was the drug release from the tablets evaluated?
The drug release from the formulated tablets was assessed using a dissolution apparatus in phosphate buffer at 37°C, measuring the % drug released at various time points.
What statistical design was utilized in the formulation optimization?
A 3^2 full factorial design was employed to evaluate and optimize the effects of Camphor and Sodium deoxycholate concentrations on drug release and permeation characteristics.
What were the stability findings for the optimized batch of tablets?
The stability study indicated that the optimized batch B9 remained stable at room temperature and accelerated conditions for one month, with minimal changes observed in drug release and permeation.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “Mouth dissolving tablet formulation and evaluation of bambuterol HCl”. 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) Drug:
A drug is a substance that is used for medical purposes, specifically for the diagnosis, treatment, or prevention of diseases. In the context of this study, Bambuterol Hydrochloride is the active pharmaceutical ingredient that exhibits antiasthmatic properties, helping to alleviate symptoms associated with asthma and chronic respiratory disorders.
2) Study (Studying):
In this context, a study refers to a systematic investigation aimed at understanding a specific hypothesis or research question. The study focuses on the formulation and evaluation of a mouth dissolving tablet of Bambuterol Hydrochloride, examining various parameters to optimize drug release and improve patient compliance.
3) Camphor:
Camphor is an organic compound commonly used in pharmaceutical formulations as a subliming agent. In the study, it plays a crucial role in formulating mouth dissolving tablets. By allowing the tablet to disintegrate rapidly upon contact with saliva, it enhances the drug's bioavailability and efficacy for asthmatic patients.
4) Table:
In this document, 'table' often refers to organized data that presents results from various experiments, such as the release rates of the drug under different conditions. Tables serve as a visual aid to understand the quantitative aspects of the formulation, facilitating comparison and analysis of the different batches evaluated.
5) Gujarat:
Gujarat is a state in India where the research was conducted, specifically at the Parul Institute of Pharmacy, Vadodara. The geographical location is relevant as it may influence the availability of raw materials or regulatory environments impacting the formulation and testing of pharmaceuticals within that region.
6) Discussion:
Discussion in research refers to the section where results are analyzed, interpreted, and compared with existing literature. It provides insights into the significance of findings, such as the stability of the optimized batch and its implications on the formulation's effectiveness, ensuring that conclusions drawn are scientifically valid.
7) Surface:
In the context of this study, 'surface' often pertains to the surface area of the tablets or the surface phenomena during drug release. The surface characteristics can significantly affect the rate of dissolution and permeation of the drug, thereby influencing its bioavailability and therapeutic effectiveness.
8) India:
India is the country where this research is conducted, highlighting the relevance of regional health concerns, pharmaceutical practices, and regulatory guidelines. The study of Bambuterol Hydrochloride mouth dissolving tablets is significant for meeting the healthcare needs of the Indian population, particularly those suffering from respiratory illnesses.
9) Inflammation:
Inflammation is an immune response that occurs in various diseases, including asthma. In terms of this study, understanding inflammation helps to identify how antiasthmatic drugs like Bambuterol Hydrochloride mitigate bronchial inflammation and obstructive airway symptoms, ultimately improving the quality of life for affected individuals.
10) Substance:
A substance refers to any material or combination of materials under investigation. In this study, Bambuterol Hydrochloride is the primary substance being formulated into mouth dissolving tablets. Knowing the characteristics and interactions of this substance with excipients is key to developing an effective pharmaceutical product.
11) Disease:
Disease refers to a pathological condition characterized by an impairment of normal bodily functions. Asthma, the disease addressed in this study, significantly affects respiratory function. The formulation of mouth dissolving tablets aims to provide an effective and patient-friendly treatment option to manage asthma more effectively.
12) Medium:
In the context of this study, 'medium' often refers to the dissolution medium, which is essential for conducting drug release studies. The choice of medium (such as phosphate buffer) is crucial as it mimics physiological conditions, allowing researchers to assess how well the drug releases and its bioactivity in the human body.
13) Powder:
Powder refers to the physical form of the excipients and active ingredient before tablet formulation. The study explores the proper blending of powders to ensure uniformity and consistency, leading to effective tablet compression and ultimately impacting the dissolution rate and bioavailability of the drug.
14) Water:
Water is essential for the disintegration of mouth dissolving tablets upon ingestion. The formulation must be designed to rapidly interact with saliva, which is primarily water, allowing efficient dissolution and absorption of the active ingredient. It plays a critical role in patient compliance due to the drug's ease of administration.
15) Post:
In pharmaceutical contexts, 'post' often relates to post-compression evaluation parameters of the formulated tablets. This includes assessments like thickness, hardness, and drug release rates. Understanding post-compression characteristics is crucial for ensuring the final product meets quality standards and efficacy for therapeutic use.