Optimizing oral antibiotic formulation for better pediatric compliance
Journal name: World Journal of Pharmaceutical Research
Original article title: Formulation, optimization and evaluation of oral antibiotic formulation to increase pediatric compliance
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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Nandini Banerjee, Sushma Singh
World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: Formulation, optimization and evaluation of oral antibiotic formulation to increase pediatric compliance
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
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Summary of article contents:
Introduction
In the realm of pediatric healthcare, ensuring drug compliance remains a significant challenge, especially given the high rates of non-compliance observed among young patients, often attributed to taste aversion and adverse effects. This study aimed to enhance patient compliance through the formulation of floating microspheres of cefpodoxime proxetil, an antibiotic commonly prescribed for pediatric ailments. The objective was to develop orally disintegrating minitablets that would mask the drug's bitter taste while providing sustained drug release over an extended period. The formulation utilized various polymers and superdisintegrants, and the final product was subjected to extensive optimization and evaluation to assess its viability as a pediatric therapeutic option.
Taste Masking Mechanism
One of the significant challenges in formulating medications for children is the bitter taste associated with many active ingredients, which can lead to non-compliance. The study highlighted the taste masking capabilities of coating cefpodoxime proxetil with polymers such as Hydroxypropyl Methylcellulose (HPMC) and Ethyl Cellulose. This coating serves as a physical barrier between the drug and taste buds, effectively reducing the solubility of the drug in saliva and masking its bitterness. The resulting minitablets exhibited a significantly improved taste profile, with evaluations from volunteers indicating a transition from highly bitter to pleasant taste scores, thus addressing a critical factor in pediatric medication adherence.
Formulation and Optimizations
In the formulation of the orally dispersible minitablets, various concentrations of superdisintegrants, namely Crosscarmellose Sodium and Sodium Starch Glycolate, were tested to optimize dispersion time, hardness, and in-vitro drug release. The study utilized a factorial design approach to assess the impact of these variables, revealing that increasing the concentration of Crosscarmellose Sodium resulted in reduced dispersion time, a critical parameter for effective oral administration in pediatric patients. The optimization process culminated in developing a formulation with desirable physical properties, successfully balancing hardness and rapid disintegration rates.
Stability Studies and Kinetic Release
Extensive stability studies were conducted to assess the formulation's integrity over a six-month period under accelerated storage conditions. The results indicated that the drug’s content remained stable throughout the study, with minimal changes in physical parameters, suggesting that the oral minitablets maintain efficacy over time. Kinetic release modeling was employed to understand the drug release mechanism, with findings indicating that the formulation follows a Fickian diffusion mechanism. This insight is essential for predicting the therapeutic behavior of cefpodoxime proxetil in the pediatric population.
Conclusion
The successful formulation of cefpodoxime proxetil into orally disintegrating minitablets represents a significant advancement in pediatric pharmacotherapy. By addressing taste aversion through effective taste masking and optimizing drug release characteristics, the formulation enhances patient compliance, which is crucial for the successful treatment of common pediatric infections. The comprehensive evaluation of the formulation's stability and release kinetics demonstrates its potential as a reliable drug delivery system, paving the way for improved medication adherence in young patients facing various health challenges.
FAQ section (important questions/answers):
What was the goal of the study conducted by Nandini et al.?
The study aimed to formulate cefpodoxime proxetil floating microspheres and create orally disintegrating minitablets to enhance patient compliance among pediatric patients by masking the drug's bitter taste.
What polymers were used in the coating of cefpodoxime proxetil?
Cefpodoxime proxetil was coated with Hydroxypropyl methyl cellulose K15 M (HPMC K15 M) and Ethyl Cellulose to mask the bitter taste and ensure sustained drug release.
How were the orally disintegrating minitablets prepared?
The minitablets were prepared by mixing the coated drug with superdisintegrants, mannitol, and other excipients, followed by direct compression using a tablet compression machine.
What methods were used to evaluate the minitablets?
Parameters such as hardness, friability, dispersion time, drug content, and in vitro drug release were evaluated along with taste masking studies using human volunteers.
What stability studies were conducted during the research?
The stability studies involved assessing the formulation at 40°C and 75% RH over six months, evaluating physical parameters, drug content, and performing HPLC analysis for impurity detection.
How effective was the taste masking for the minitablets?
The taste masking was successful, with the coated drug scored as tasteless and the final minitablet judged to have a pleasant taste by volunteer panel testing.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “Optimizing oral antibiotic formulation for better pediatric compliance”. 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:
The term 'Drug' refers to a chemical substance used in the diagnosis, treatment, or prevention of diseases. In the context of the study, cefpodoxime proxetil is the antibiotic examined, highlighting the importance of drug formulation for specific populations, particularly pediatrics to improve compliance and efficacy in treatment.
2) Nandini (Nandinī, Namdini):
Nandini is the name of the primary author of the research article. It signifies the individual responsible for the research and development of the oral antibiotic formulation. Authors' names reflect the contributors' efforts and expertise in pharmaceutical sciences, underscoring the collaborative nature of scientific research.
3) Table:
The term 'Table' in this context refers to a tabular format used to present data clearly, such as the composition of different formulations or results from various tests. Tables enhance the readability and comprehensibility of complex data, allowing for easier comparison and analysis of experimental results.
4) Study (Studying):
The term 'Studying' encompasses the investigative activities undertaken in research to explore hypotheses, assess results, and identify new knowledge within pharmaceutical sciences. It signifies the continuous learning process vital for innovation and improving healthcare outcomes, particularly in drug formulation.
5) Antibiotic (Antibacterial):
An 'Antibiotic' is a type of medication used to treat bacterial infections. In this research, cefpodoxime proxetil, a semi-synthetic beta-lactam antibiotic, is emphasized for its effectiveness against pediatric infections. Understanding antibiotics is crucial for developing effective treatments and managing resistant strains of bacteria.
6) Surface:
The term 'Surface' refers to the outer layer of the tablets or microspheres that can interact with the environment or biological systems. In the formulation context, surface characteristics influence drug release rates and stability, vital in developing effective pharmaceutical dosage forms that ensure optimal therapeutic outcomes.
7) Bitter:
'Bitter' describes one of the primary taste sensations that can deter patient compliance, particularly in children. The study addresses taste masking techniques to reduce bitterness, thereby improving the acceptability of antibiotic formulations, which is crucial for ensuring that patients complete their medication regimens.
8) Kumar (Kumār):
Kumar represents a common surname, possibly denoting one of the referenced authors in the research. It reflects the collaborative nature of the study, which may include a diverse group of researchers. This indicates the inclusivity and support network typical in pharmaceutical research endeavors.
9) Water:
'Water' serves as a solvent in various experimental protocols, particularly in drug formulation and dissolution testing. Its role is crucial for creating solutions that facilitate drug delivery, as well as for simulating biological conditions in vitro, ensuring that tests accurately reflect in vivo behavior.
10) Medium:
The term 'Medium' refers to the environment or solution in which drug release and absorption studies are conducted. In this context, simulated saliva or dissolution media represent the conditions that mimic the human body, thus allowing for realistic assessments of drug formulation performance.
11) India:
India is the geographical location where the research was conducted and where the author institutions are located. Its significance underscores the regional focus on improving pediatric healthcare, reflecting the demographic needs and the public health challenges faced within the country's healthcare system.
12) Patel (Paṭel, Pāṭel):
Patel is another surname likely referring to a contributing author in the publication. Including multiple authors' names illustrates the collaborative effort in the research, emphasizing that pharmaceutical studies often leverage diverse expertise in drug formulation and evaluation for better outcomes.
13) Miṇi (Mini):
'Mini' refers to the size of the tablets developed in the study—specifically, minitablets. These dosage forms cater to pediatric patients, providing easier administration and aiding compliance. Minitablets represent a significant trend in pharmaceutical formulations aimed at improving patient experience and outcomes.
14) Maharashtra (Mahārāṣṭra, Maha-rashtra):
Maharashtra is the Indian state where the research institution is located. It is notable for its advancements in healthcare and pharmaceutical industries, contributing to the overall development of innovative drug delivery systems designed for diverse patient populations.
15) Disease:
'Disease' refers to the medical conditions targeted by the antibiotic formulation. This study specifically addresses diseases prevalent in pediatrics, stressing the importance of tailored therapeutic approaches to ensure effective management and treatment adherence among young patients.
16) Science (Scientific):
'Scientific' pertains to the methodical approach and standards applied in the research. This term underscores the reliance on empirical evidence and defined procedures, essential in validating the findings and ensuring advancements in drug delivery systems are reliable, effective, and reproducible.
17) Gupta (Guptā):
Gupta represents another author within the study, reflecting the collaborative effort involved in the research. The inclusion of multiple names signifies a multi-disciplinary approach typical of pharmaceutical studies, where pooling expertise leads to more comprehensive innovations in drug formulations.
18) Campu (Campū, Cāmpu):
'Campu', likely a typo of 'Campus', refers to the educational institution involved in the research. It signifies the academic setting where knowledge is generated, promoting research agendas that focus on developing safe and effective medications for pediatric care.
19) Raghavendra (Rāghavendra):
Raghavendra is another author, showcasing the contribution of various researchers to the study. Each author's involvement emphasizes the collaborative nature of scientific research, where diverse perspectives and expertise converge to create innovative solutions in pharmaceuticals.
20) Inference:
Inference refers to the conclusions drawn from the study's results. In scientific research, it entails interpreting data to understand mechanisms, effectiveness, and implications of drug formulations. Inference is crucial for guiding future research, clinical practices, and recommendations derived from the findings.
21) Substance:
'Substance' refers to any material with defined physical properties, such as the drug itself, excipients, or polymers used for coating. It highlights the foundational aspects of pharmaceutical formulations, where understanding the characteristics of each substance directly impacts the efficacy and safety of the final product.
22) Container:
The term 'Container' may refer to the packaging or storage recipients used for the formulated minitablets. Proper containment is essential for maintaining stability, preventing contamination, and ensuring the longevity of pharmaceutical products, which is crucial for safe distribution and effectiveness.
23) Swallowed:
'Swallowed' pertains to the action of ingesting medication whole. In pediatric care, swallowing difficulties may hinder treatment adherence. This study addresses the design of minitablets, which are easier for children to handle and consume, thereby improving the likelihood of successful therapy.
24) Crushing:
'Crushing' refers to the mechanical process applied to tablets to facilitate their ingestion or for specific formulations. Understanding the implications of crushing medications is essential, especially when developing pediatric formulations that must ensure both safety and patient acceptance.
25) Gelatin:
'Gelatin' refers to a polymer that can be used in pharmaceutical formulations, especially for coating or encapsulating substances to prevent bitterness. Its mention suggests exploring different taste-masking agents or excipients to enhance patient compliance, particularly for formulations targeted at children.
26) Sharman (Śarma, Sarmā, Sarma, Sharma, Śarman):
Sharma is another author associated with the research, highlighting the collaborative nature of scientific inquiry. Each author's contribution reflects their expertise, which is critical for developing effective formulations and ensuring that diverse perspectives are represented in the research process.
27) Filling (Filled):
'Filled' likely refers to the process of incorporating active substances and excipients into the tablet matrix. This term emphasizes the formulation aspect of the research, specifically how the components are combined to create stable and effective drug delivery systems.
28) Bhati (Bhaṭi, Bhāti, Bhāṭi, Bhātī):
Bhati is another surname indicating a contributor to the study. The inclusion of multiple authors points to the collaboration and teamwork inherent in pharmaceutical research. Contributions from various experts enhance the quality and thoroughness of the research process.
29) Roman (Roma):
'Roman' likely refers to an author, emphasizing the collaborative nature of the research. In scientific literature, co-authors contribute to the depth and breadth of knowledge, representing diverse areas of expertise that are valuable in tackling complex pharmaceutical challenges.
30) Glass:
'Glass' typically refers to the type of laboratory equipment used in experiments. In this study's context, it may indicate the use of glassware for dissolution testing or formulation processes, which is essential for maintaining the integrity and accuracy of the conducted experiments.
31) Visit:
The term 'Visit' may metaphorically refer to the approach taken by researchers in acquiring necessary data or insights through exploratory studies—understanding the practical implications of their research findings and the real-world application of their developed formulations.
32) Dama (Dāma, Dāmā, Ḍama, Ḍāma):
Dama is likely an author associated with the research, reflecting the collaborative nature of academic studies. Each author's unique perspective contributes to the overall research quality, highlighting the importance of teamwork in the complex field of pharmaceutical development.
33) Ravi (Rāvī, Rāvin, Ravin):
Ravi, as an author, denotes the collaborative effort involved in the research article. The inclusion of diverse scholars showcases the interdisciplinary nature of the study, where varying expertise comes together to address specific health challenges in the pediatric population.
34) Puri (Purī):
Puri is likely another contributing author, indicating a multi-author collaboration that is typical in scientific research. The collective expertise and guidance from multiple authors help strengthen the study's integrity and inform its conclusions on pediatric pharmaceutical formulations.
35) Babu (Bābū):
Babu refers to an author, further suggesting the collaborative nature of the research. Each author's contribution plays a crucial role in the development of effective drug formulations, emphasizing how teamwork fosters innovation in the pharmaceutical industry.
36) Dish (Diś):
In this context, 'Dish' may refer to the glassware used for conducting experiments, particularly those involving dissolution or taste testing. It underscores the practical aspects of experimental design and the environments created for effective drug formulation evaluation.
37) Male (Mālē):
The term 'Male' suggests the demographic focus of the study participants during clinical evaluations. In studies on drug formulation and evaluation, it is essential to consider gender, as physiological differences can impact drug absorption, effectiveness, and compliance aspects.
38) Food:
The term 'Food' highlights the importance of taste and acceptability in drug formulations. Since many pediatric patients might resist medication, factors such as how a drug is perceived in taste (often related to food) significantly affect compliance and therapeutic success.
39) Life:
'Life' refers to the broader concept encompassing health, wellness, and treatment efficacy. In the context of the study, it addresses the impact that effective drug formulations can have on enhancing the quality of life for pediatric patients through improved health outcomes.
40) Line:
The term 'Line' may refer to a line of products or a methodical path taken in research. It symbolizes the structured approach to scientific inquiry and indicates the development of a series of formulations targeting specific health needs in children.
41) Hadi (Haḍi):
Hadi likely represents an author in the research study, signifying the collective academic contributions within the outlined work. Each author's expertise highlights the collaborative efforts necessary in formulating effective delivery systems tailored for pediatric use.