Nevine Shawky Abd El-Malak
Bio: Nevine Shawky Abd El-Malak is an academic researcher from Cairo University. The author has contributed to research in topic(s): Dissolution testing. The author has an hindex of 2, co-authored 3 publication(s) receiving 125 citation(s).
Topics: Dissolution testing
TL;DR: Findings suggest that the fast orodispersible film containing tianeptine is likely to become one of choices for acute treatment of depression.
Abstract: The present investigation was undertaken with the objective of formulating orodispersible film(s) of the antidepressant drug tianeptine sodium to enhance the convenience and compliance by the elderly and pediatric patients. The novel film former, lycoat NG73 (granular hydroxypropyl starch), along with different film-forming agents (hydroxypropyl methyl cellulose, hydroxyethyl cellulose, and polyvinyl alcohol), in addition to three film modifiers; namely, maltodextrin, polyvinyl pyrrolidone K90 and lycoat RS780 (pregelatinized hydroxypropyl starch) were evaluated. Eight formulae were prepared by the solvent-casting method; and were evaluated for their in vitro dissolution characteristics, in vitro disintegration time, and their physico-mechanical properties. The promising orodispersible film based on lycoat NG73 (F1); showing the greatest drug dissolution, satisfactory in vitro disintegration time and physico-mechanical properties that are suitable for orodispersible films, was evaluated for its bioavailability compared with a reference marketed product (Stablon® tablets) in rabbits. Statistical analysis revealed no significant difference between the bioavailability parameters (C max (ng/ml), t max (h), AUC0–t (ng h ml−1), and AUC0–∞ (ng h ml−1)] of the test film (F1) and the reference product. The mean ratio values (test/reference) of C max (89.74%), AUC0–t (110.9%), and AUC0–∞ (109.21%) indicated that the two formulae exhibited comparable plasma level-time profiles. These findings suggest that the fast orodispersible film containing tianeptine is likely to become one of choices for acute treatment of depression.
Abstract: Drotaverine hydrochloride (DRH) is an antispasmodic drug which has a short residence in the intestine during diarrhea that prompts poor bioavailability and frequent dosing. The aim of the present study was to increase the gastric residence time and sustain the release of DRH so increasing patient compliance. Nine floating mini-tablets of DRH were prepared employing different amounts of sodium alginate and sodium bicarbonate by wet granulation technique adopting 32 factorial design. The prepared formulae were evaluated for various physical parameters, floating behaviors and in vitro release studies. Formula FF9 (sodium alginate 200 mg and sodium bicarbonate 120 mg) showed optimum floating behavior (floating lag time 49.1 ± 5.3 s and total floating time ˃ 24 h) and optimum sustained release for DRH (7.60 ± 1.25% after 0.5 h and 78.14 ± 3.10% after 12 h). The candidate formula with the highest desirability value (0.942) was evaluated for its bioavailability compared to the marketed product. Statistical analysis revealed significant increase in AUC(0-∞) 3311.31 ± 182.18 ng h/ml with delayed Tmax compared to 1589.54 ± 127.97 ng h/ml for the marketed product. The results revealed that FF9 could be a promising candidate for gastroretentive drug delivery system for DRH.
Abstract: Erratum to: AAPS PharmSciTech DOI 10.1208/s12249-010-9464-2 Regarding the co-author, please note that the correct given name is Nevine Shawky and the correct family name is Abd El-Malak. The original article contains an incorrect reference citation. At the end of the first sentence in the second paragraph of the RESULTS AND DISCUSSION section, (8, 26) should be (9, 26).
TL;DR: The aim of this review is to provide an overview of the critical factors affecting the formulation of thin films, including the physico-chemical properties of polymers and drugs, anatomical and physiological constraints, as well as the characterization methods and quality specifications to circumvent the difficulties associated with formulation design.
Abstract: Pharmaceutical scientists throughout the world are trying to explore thin films as a novel drug delivery tool. Thin films have been identified as an alternative approach to conventional dosage forms. The thin films are considered to be convenient to swallow, self-administrable, and fast dissolving dosage form, all of which make it as a versatile platform for drug delivery. This delivery system has been used for both systemic and local action via several routes such as oral, buccal, sublingual, ocular, and transdermal routes. The design of efficient thin films requires a comprehensive knowledge of the pharmacological and pharmaceutical properties of drugs and polymers along with an appropriate selection of manufacturing processes. Therefore, the aim of this review is to provide an overview of the critical factors affecting the formulation of thin films, including the physico-chemical properties of polymers and drugs, anatomical and physiological constraints, as well as the characterization methods and quality specifications to circumvent the difficulties associated with formulation design. It also highlights the recent trends and perspectives to develop thin film products by various companies.
TL;DR: The magnitude of variants of ODF technology and the advantages over conventional dosage forms promise more applications and more marketed products with ODFs in the near future.
Abstract: Introduction: Orodispersible films for oral delivery are gaining popularity. Whereas breath-fresheners and over-the-counter products have already become quite common in the US, the first prescription drug films were introduced into the EU and US markets only very recently. Already considered as a unique Rx (prescription drug) dosage form by the FDA (oral soluble film), such products are not substitutable by conventional oral dosage forms. The official term defined by the European Medicines Agency is orodispersible film (ODF). Areas covered: This review gives an overview on the benefits of ODFs, typical excipients and products already available on the market. ODFs are defined and differentiated from other films and dosage forms. Possible manufacturing methods are described. As ODFs are not yet listed in one of the pharmacopoeias, possible methods for characterization and quality control are discussed. Required characteristics, advantages and disadvantages are elaborated. Biopharmaceutical considerations ar...
TL;DR: As the drug is directly absorbed into systemic circulation, degradation in gastrointestinal tract and first pass effect can be avoided, these points make this formulation most popular and acceptable among pediatric and geriatric patients and patients with fear of choking.
Abstract: Recently, fast dissolving films are gaining interest as an alternative of fast dissolving tablets. The films are designed to dissolve upon contact with a wet surface, such as the tongue, within a few seconds, meaning the consumer can take the product without need for additional liquid. This convenience provides both a marketing advantage and increased patient compliance. As the drug is directly absorbed into systemic circulation, degradation in gastrointestinal tract and first pass effect can be avoided. These points make this formulation most popular and acceptable among pediatric and geriatric patients and patients with fear of choking. Over-the-counter films for pain management and motion sickness are commercialized in the US markets. Many companies are utilizing transdermal drug delivery technology to develop thin film formats. In the present review, recent advancements regarding fast dissolving buccal film formulation and their evaluation parameters are compiled.
TL;DR: This pharmaceutical form with a blustering beginning as a breath freshener had an emergent entrance in the Rx market proving its reliable value, and is described and explores the oral film technology from its main component, the polymeric matrices, to the new and possible market applications.
Abstract: Polymers are the most common excipients used in pharmaceutical dosage forms, and often new applications and innovative polymers appear aiming to overcome unmet needs in the drug formulation field. Orodispersible dosage forms based on polymeric matrices have currently demonstrated their prominence in accordance with the actual market requirements and patients' demands. The versatility of the polymeric oral films had proven their high value as suitable technological platforms for extension and adjustment to different delivery routes and promising markets. These are the main reasons for the increasing investment of several companies in this technology and their applicability in different therapeutic segments. This pharmaceutical form with a blustering beginning as a breath freshener had an emergent entrance in the Rx market proving its reliable value. This review describes and explores the oral film technology from its main component, the polymeric matrices, to the new and possible market applications, highlighting all the critical and important points of its development.
TL;DR: Orally disintegrating films have potential for business and market exploitation because of their myriad of benefits over orally disintegrating tablets and the market prospect of this innovative dosage form is also targeted.
Abstract: Over the past few decades, tendency toward innovative drug delivery systems has majorly increased attempts to ensure efficacy, safety and patient acceptability. As discovery and development of new chemical agents is a complex, expensive and time consuming process, so recent trends are shifting toward designing and developing innovative drug delivery systems for existing drugs. Out of those, drug delivery system being very eminent among pediatrics and geriatrics is orally disintegrating films (ODFs). These fast disintegrating films have superiority over fast disintegrating tablets as the latter are associated with the risks of choking and friability. This drug delivery system has numerous advantages over conventional fast disintegrating tablets as they can be used for dysphasic and schizophrenic patients and are taken without water due to their ability to disintegrate within a few seconds releasing medication in mouth. Various approaches are employed for formulating ODFs and among which solvent casting and spraying methods are frequently used. Generally, hydrophilic polymers along with other excipients are used for preparing ODFs which allow films to disintegrate quickly releasing incorporated active pharmaceutical ingredient (API) within seconds. Orally disintegrating films have potential for business and market exploitation because of their myriad of benefits over orally disintegrating tablets. This present review attempts to focus on benefits, composition, approaches for formulation and evaluation of ODFs. Additionally, the market prospect of this innovative dosage form is also targeted.