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Background: Theophylline (THN), a bronchodilator with potential applications in emerging conditions like COVID-19, requires a controlled-release delivery system due to its narrow therapeutic range and short half-life. This need is particularly crucial as some existing formulations demonstrate impaired functionality. This study aims to develop a new 12-h controlled-release matrix system (CRMS) in the form of a capsule to optimize dosing intervals. Methods: CRMSs were developed using varying proportions of poloxamer 407 (P-407), stearyl alcohol (STA), and hydroxypropyl methylcellulose (HPMC) through the fusion technique. Their in vitro dissolution profiles were then compared with an FDA-approved THN drug across different pH media. The candidate formulation underwent characterization using X-ray diffraction, scanning electron microscopy, Fourier transform infrared spectroscopy, differential scanning calorimetry, and thermogravimetric analysis. Additionally, a comprehensive stability study was conducted. Results: In vitro studies showed that adjusting the concentrations of excipients effectively controlled drug release. Notably, the CRMS formulation 15 (CRMS-F15), which was composed of 30% P-407, 30% STA, and 10% HPMC, closely matched the 12 h controlled-release profile of an FDA-approved drug across various pH media. Characterization techniques verified the successful dispersion of the drug within the matrix. Furthermore, CRMS-F15 maintained a consistent controlled drug release and demonstrated stability under a range of storage conditions. Conclusions: The newly developed CRMS-F15 achieved a 12 h controlled release, comparable to its FDA-approved counterpart.
Controlled-release drug delivery systems (CDDSs) have significantly transformed the pharmaceutical field. These systems are designed to administer medication in a regulated way over a prolonged period, effectively minimizing the need for frequent dosing [1]. This can improve patient adherence to the medication and overall treatment outcomes [2]. Various additional benefits can be obtained from developing CDDSs, as shown in . Various types of medication require the utilization of CDDSs: for instance, drugs with a short half-life, such as furosemide [3], oxcarbazepine [4], and metoprolol [5], as well as medications with a narrow therapeutic window like theophylline monohydrate (THN) [6,7], lithium [8], and phenytoin [9]. However, the development of new CDDSs faces a range of challenges that must be addressed.
New controlled-release (CR) compounds require sufficient stability within the gastrointestinal tract (GIT) while releasing the drug molecules at predetermined intervals. Several medications have been recalled from the market for not meeting dissolution specifications, such as metformin CR tablets [10], Adderall CR tablets [11], indapamide CR tablets [12], and metoprolol succinate CR tablets [11,13]. The frequent recalls of CR medications and the importance of CDDSs in the pharmaceutical industry highlight the ongoing potential for advancements in CDDS development [4,14,15,16]. Thus, the primary objective of this research was to develop new CDDSs suitable for Biopharmaceutical Classification System (BCS) Class I medications, utilizing a minimal number of excipients and a convenient preparation method.
The model drug for this study was THN. THN was selected due to the reported challenges in maintaining controlled drug release functionality in some THN CR formulations [17,18]. Additionally, delivering THN in a CR system is preferred due to its rapid absorption, narrow therapeutic window (10 to 20 mg/mL), and short half-life (7 to 9 h) [6,7]. THN is mainly used for chronic obstructive pulmonary disease (COPD) and asthma [6,19]. Additionally, recent research has shown some potential new pharmacological benefits of THN, for instance, in managing COVID-19 [20] and post-tubercular lung illnesses [21], and as an effective alternative to permanent pacemaker implantation [22].
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The matrix system stands out among the different developed CDDSs due to its simplicity in manufacturing, cost-effectiveness, and predictable drug release kinetics among other different features, as demonstrated in [3]. In a matrix system, the active pharmaceutical ingredient (API) is uniformly dispersed within a polymeric matrix, effectively controlling the drug release rate [23]. There is a wide range of excipients used in the production of a matrix system. The selection of the matrix polymer depends on the desired release profile, method of preparation, and API characteristics, as well as on the various properties of the excipients [24,25,26,27].
In this study, three excipients were selected to develop a new controlled-release matrix system (CRMS). These chosen excipients were poloxamer-407 (P-407), hydroxypropyl methylcellulose (HPMC), and stearyl alcohol (STA). These excipients were chosen based on their physicochemical properties and their effectiveness in retarding drug release according to different research studies [28,29,30,31]. For instance, an in situ gel delivery system combining P-407 and methylcellulose prolonged drug release compared to administering the drug freely [32]. Another study developed an intragastric floating tablet using HPMC and polylactic acid (PLA) that controlled drug release for 24 h [2]. Similarly, STA and HPMC in a CRMS extended the release of sarpogrelate HCL for 24 h [25].
P-407 is extensively utilized in the creation of drug delivery systems (DDSs) due to its various properties. It is known to be non-toxic [33,34], exhibits excellent compatibility [28,33], and has a high capacity to solubilize various medications [33,34]. The ability of P-407 to control drug release is attributed to the amphiphilic nature of poloxamers. This contributes to the formation of a gel around the formulation, which retards the rapid release of the drug molecules [1,31,35,36].
HPMC has a wide range of applications, for instance, as a thickener, emulsifier, and stabilizer [37,38], owing to its compatibility, excellent safety profile, and stability [29]. Moreover, the utilization of HPMC to control drug release is attributed to its capacity to form a gel upon contact with water, establishing a dynamic barrier that controls the drug release rate, as has been reported in the literature [31,39].
STA has diverse applications that are attributed to its unique characteristics, including its emollient properties, viscosity enhancement, pH stability, and non-toxicity [30,40]. Additionally, STA in a CR formulation has the ability to form a hydrophobic domain that hinders drug diffusion and extends release duration [40].
The current study aimed to develop and evaluate a novel matrix-based controlled-release system tailored for THN, a BCS Class 1 drug. Utilizing the fusion method, the system incorporates P-407, STA, and HPMC, and is encapsulated in a size 00 capsule.
In this study, several formulations with varying polymer ratios and types were prepared. These were assessed using an in vitro dissolution apparatus in media with different incubated pH levels (1.2, 4.5, and 7.5) to simulate varying gastrointestinal environments. Additionally, drug release kinetics were determined to elucidate the drug&#;s release mechanism from the matrix system. The selected formulation was comprehensively characterized through X-ray diffraction (XRD), scanning electron microscopy (SEM), Fourier transform infrared (FTIR) analysis, differential scanning calorimetry (DSC), and thermogravimetric analysis (TGA). Stability studies were also conducted, involving the exposure of the formulations to various temperatures and humidity levels over a period of 72 h. Additionally, their stability under constant conditions was assessed over a storage period of three months.
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