Factorial study of ropinirole hydrochloride transdermal films.
Journal name: World Journal of Pharmaceutical Research
Original article title: A factorial study, formulation and evaluation ropinirole hydrochloride transdermal films
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.
This page presents a generated summary with additional references; See source (below) for actual content.
Summary of article contents:
Introduction
The research article presents a study on the formulation and evaluation of transdermal films containing Ropinirole Hydrochloride, aimed at providing a sustained release drug delivery system for the treatment of Parkinson’s disease and Restless Legs Syndrome. The study utilized HPMC K4M as a polymer and PEG 400 as a plasticizer, employing a solvent evaporation method to prepare the transdermal films. The formulations were systematically designed using a 3² full factorial design to optimize various parameters related to drug release and film characteristics.
Importance of Transdermal Delivery Systems
Transdermal drug delivery systems (TDDS) represent a significant advancement in the field of controlled drug delivery. By allowing drugs to be administered through the skin directly into the systemic circulation, these systems bypass many drawbacks associated with oral and parenteral routes, including first-pass metabolism and gastrointestinal irritation. The concept of TDDS has garnered attention due to its ability to provide a controlled and sustained release of medications, enhancing patient compliance and offering a non-invasive alternative to injections.
Advantages and Disadvantages of TDDS
The study identifies multiple advantages of transdermal drug delivery systems. These include providing a steady infusion of drugs, improving therapeutic outcomes by avoiding gastrointestinal issues, and allowing for self-administration while reducing dosing frequency. However, transdermal delivery also has limitations. Drugs must possess suitable physicochemical properties for effective penetration through the skin, which restricts the system to relatively potent medications. Issues such as potential contact dermatitis and variability in skin permeability further complicate the practical application of TDDS.
Formulation and Evaluation of Transdermal Films
The preparation of transdermal films involved a meticulous process that included the optimization of polymer concentrations and ensuring suitable physicochemical interactions between the drug and excipients. Various parameters were characterized, such as physical appearance, thickness, drug content uniformity, folding endurance, and in vitro drug release. The results demonstrated satisfactory characteristics, with significant drug release observed particularly in the formulation using HPMC K4M, underscoring the effectiveness of the chosen methods in developing a viable transdermal system.
Conclusion
The findings from the study suggest that transdermal films of Ropinirole Hydrochloride are a promising alternative for clinical administration in treating conditions like Parkinson’s disease and Restless Leg Syndrome. The success in achieving desired release profiles, coupled with the convenience of the transdermal delivery method, highlights the potential for these systems to improve patient compliance and therapeutic effectiveness. Continued research and development in this area hold promise for optimizing drug delivery systems tailored to meet specific medical needs.
Original source:
This page is merely a summary which is automatically generated hence you should visit the source to read the original article which includes the author, publication date, notes and references.
Harshal B. Nannaware and Dr. S. Z. Chemate
World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: A factorial study, formulation and evaluation ropinirole hydrochloride transdermal films
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
Doi: 10.20959/wjpr201710-9359
Download the PDF file of the original publication
FAQ section (important questions/answers):
What is the primary purpose of Ropinirole Hydrochloride transdermal films?
The films are designed for sustained release of Ropinirole Hydrochloride, providing a convenient administration method that avoids swallowing and the use of water, beneficial for treating Parkinson's disease and Restless Leg Syndrome.
What polymers and plasticizers were used in the transdermal films?
The transdermal films were prepared using HPMC K4M as the polymer and PEG 400 as a plasticizer, utilizing a solvent evaporation method.
How were the transdermal films evaluated for quality?
The films were evaluated based on weight uniformity, thickness, folding endurance, drug content uniformity, surface pH, and tensile strength, all yielding satisfactory results.
What are the advantages of using transdermal drug delivery systems?
Transdermal systems offer steady drug infusion, avoid first-pass metabolism, are non-invasive, can improve patient compliance, and allow for rapid termination of drug therapy.
What study design was used for optimizing the formulation?
A 3² full factorial design was applied, varying concentrations of HPMC K4M and PEG to evaluate their effects on film characteristics like drug release and thickness.
What were the results of drug release from the formulations?
The transdermal films exhibited varying drug release profiles, with the formulation containing HPMC K4M showing an impressive 98.19% drug release within 120 minutes.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “Factorial study of ropinirole hydrochloride transdermal films.”. 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:
In the context of this research, 'Drug' refers to Ropinirole Hydrochloride, a medication used for treating Parkinson’s disease and Restless Legs Syndrome. The formulation of the transdermal film aims to ensure sustained release, which is crucial for maintaining effective therapeutic levels in patients.
2) Table:
The term 'Table' relates to the organized presentation of data in the research document. Tables are used to summarize key results, such as physical properties of formulations or evaluation data, facilitating comparison and analysis in a clear and concise manner for readers.
3) Surface:
Here, 'Surface' typically pertains to the outer layer of the transdermal films. The surface quality is important for ensuring proper adhesion to the skin, drug release rates, and overall effectiveness of the transdermal delivery system.
4) Study (Studying):
'Study' encapsulates the systematic investigation conducted to analyze the efficacy and characteristics of the transdermal films containing Ropinirole Hydrochloride. This involves experimental design, evaluation of formulation parameters, and assessments of drug release profiles.
5) Water:
'Water' is significant in this context as a solvent used during the preparation of the transdermal films and for dissolving Ropinirole Hydrochloride for drug content uniformity testing. It is also a medium in which the drug release studies were carried out.
6) Ahmednagar:
Ahmednagar refers to the location where the study was conducted, specifically at Dr. V.V.P.F’s College of Pharmacy. This geographical context provides insights into the academic and research environment that supports pharmaceutical innovations, including transdermal delivery systems.
7) Glass:
The term 'Glass' in the document relates to the glass ring mold used for casting the transdermal films. Glass is important for its inert properties, preventing any interaction with the drug or excipients during formulation.
8) Ghat (Gham):
'Ghat' is part of the name of the location, Vilad Ghat, where the study was conducted. In the context of 'Ahmednagar', this local significance might contribute to regional knowledge in pharmaceutical research and development.
9) Disease:
'Disease' in this context refers to Parkinson’s disease, a direct indication of the target ailment for which Ropinirole Hydrochloride is administered. Accurate delivery of this drug is crucial for the management of symptoms associated with such diseases.
10) Powder:
'Powder' pertains to the physical form of Ropinirole Hydrochloride. The characteristics of the drug powder, including solubility and flowability, affect the formulation process for the transdermal films and subsequent drug release.
11) Field:
'Field' relates to the area of pharmaceutical research being focused on in the document, which is the development of transdermal drug delivery systems. It emphasizes the innovative approaches within the broader pharmaceutical industry aimed at improving therapy and patient care.
12) Pain:
'Pain' refers to one of the symptoms managed with Ropinirole Hydrochloride in conditions like Parkinson's disease. Understanding effective methods of delivering pain relief through transdermal systems is essential for improving patients' quality of life.
13) Dish (Dis):
'Dish' refers to the Petri dish used during the preparation of the transdermal films. This laboratory equipment is vital for providing a controlled environment for film casting and subsequent drying processes.
14) Pharmacological:
'Pharmacological' relates to the branch of medicine concerned with the uses, effects, and mechanisms of action of drugs. This research targets the pharmacological properties of Ropinirole Hydrochloride in achieving effective therapeutic outcomes.
15) Measurement:
'Measurement' in this context involves the quantification of various parameters of the transdermal films, such as thickness, drug content uniformity, and tensile strength. Accurate measurements are essential for ensuring the consistency and reliability of the formulated products.
16) Observation:
'Observation' refers to the systematic examination of the physical and chemical properties of the transdermal films. This includes noting characteristics during experiments, which informs conclusions and recommendations regarding the effectiveness of the formulations.
17) Discussion:
'Discussion' refers to the analysis and interpretation of results obtained from the experiments conducted. This section highlights the implications of the findings, comparing them with existing literature and suggesting future research directions.
18) Developing:
'Developing' emphasizes the active process of creating and optimizing the transdermal films using Ropinirole Hydrochloride. This term underscores the innovation involved in formulating a therapeutic delivery system that improves patient compliance.
19) Swallowing:
'Swallowing' signifies a common route of drug administration that poses challenges for some patients, particularly the elderly or those with dysphagia. Transdermal delivery systems provide a viable alternative for these individuals, bypassing the need to ingest medication.
20) Irritation:
'Irritation' is a potential side effect associated with transdermal systems, often due to skin reactions. Evaluating formulations for irritation potential is essential for patient safety and comfort, ensuring the system is both effective and tolerable.
21) Substance:
'Substance' generally refers to the chemical compounds involved in the study, particularly Ropinirole Hydrochloride and its excipients. Understanding the properties of these substances is crucial for determining their compatibility and effectiveness in the transdermal film.
22) Vomiting:
'Vomiting' is a symptom effectively managed by Ropinirole Hydrochloride, underscoring the importance of efficient drug delivery systems. The study indirectly addresses this symptom by focusing on routes of administration that enhance therapeutic effects.
23) Hanging:
'Hanging' refers to the method employed during the testing of tensile strength of the transdermal films. This mechanical test involves suspending the film to measure its resistance to breaking when subjected to force, providing critical data on film strength.
24) Itching:
'Itching' is a common adverse response at the application site of transdermal patches. Managing this side effect is vital for patient adherence to treatment regimens and effective drug delivery.
25) Nausea:
'Nausea' is another symptom associated with conditions treated by Ropinirole Hydrochloride. Addressing nausea through effective transdermal pharmacotherapy is crucial, particularly for enhancing patient quality of life.
26) Purity:
'Purity' refers to the assessment of the chemical integrity of Ropinirole Hydrochloride, ensuring that it meets necessary pharmacological standards. Confirming purity is integral for guaranteeing the safety and efficacy of the developed film formulations.
27) Medium:
'Medium' commonly refers to the solvent or environment used in experiments, such as the phosphate buffer for drug release studies. The choice of medium influences drug solubility and release kinetics, impacting overall formulation success.
28) Mukta:
'Mukta' denotes Mukta Engineering Pvt. Ltd, a supplier of excipients like HPMC K4M used in the study. This highlights the role of industry partnerships in pharmaceutical research to provide quality materials for drug formulations.
29) India:
'India' is the country where the research study was conducted, providing context to the regulatory and scientific environment within which pharmaceutical development occurs, showcasing local advancements in drug delivery technology.
30) Edema (Oedema):
'Edema' refers to the swelling caused by excess fluid accumulation, which may be a side effect associated with some patients using transdermal patches. Minimizing such effects is crucial for maintaining patient adherence and comfort.
31) Blood:
'Blood' is relevant in the assessment of drug absorption and systemic circulation, which are critical measures of the effectiveness of transdermal films in delivering therapeutic agents effectively into the bloodstream.
32) Miṇi (Mini):
'Mini' describes the type of dissolution apparatus used for the drug release tests. This suggests a focus on precision in studying drug release profiles, ensuring results are both accurate and meaningful for formulation development.
33) Male:
'Male' may refer to the demographic considerations in clinical uses of Ropinirole Hydrochloride. The understanding of sex-specific responses to medications is essential for tailoring effective treatments for both genders.
34) Life:
'Life' signifies the overall quality of life impacted by conditions like Parkinson’s disease, emphasizing the need for effective drug delivery solutions that improve the daily living and health outcomes for patients.