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Article: Excipient Impact on Fenofibrate Equilibrium Solubility in Fasted and Fed Simulated Intestinal Fluids Assessed Using a Design of Experiment Protocol.

Ainousah, Bayan E / Khadra, Ibrahim / Halbert, Gavin W

2023 Volume 15, Issue 10

Abstract: Solubility is a critical parameter controlling drug absorption after oral administration. For poorly soluble drugs, solubility is influenced by the complex composition of intestinal media and the influence of dosage form excipients, which can cause ... ...

Abstract	Solubility is a critical parameter controlling drug absorption after oral administration. For poorly soluble drugs, solubility is influenced by the complex composition of intestinal media and the influence of dosage form excipients, which can cause bioavailability and bioequivalence issues. This study has applied a small scale design of experiment (DoE) equilibrium solubility approach in order to investigate the impact of excipients on fenofibrate solubility in simulated fasted and fed intestinal media. Seven media parameters (bile salt (BS), phospholipid (PL), fatty acid, monoglyceride, cholesterol, pH and BS/PL ratio) were assessed in the DoE and in excipient-free media, and only pH and sodium oleate in the fasted state had a significant impact on fenofibrate solubility. The impact of excipients were studied at two concentrations, and for polyvinylpyrrolidone (PVP, K12 and K29/32) and hydroxypropylmethylcellulose (HPMC, E3 and E50), two grades were studied. Mannitol had no solubility impact in any of the DoE media. PVP significantly increased solubility in a media-, grade- and concentration-dependent manner, with the biggest change in fasted media. HPMC and chitosan significantly reduced solubility in both fasted and fed states in a media-, grade- and concentration-dependent manner. The results indicate that the impact of excipients on fenofibrate solubility is a complex interplay of media composition in combination with their physicochemical properties and concentration. The results indicate that in vitro solubility studies combining the drug of interest, proposed excipients along with suitable simulated intestinal media recipes will provide interesting information with the potential to guide formulation development.
Language	English
Publishing date	2023-10-17
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2527217-2
ISSN	1999-4923
ISSN	1999-4923
DOI	10.3390/pharmaceutics15102484
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Article: A Study to Assess Prescription Transfer and Medicines Collection Through a New Electronic Prescription Service: A Cross-Sectional Survey.

Tobaiqy, Mansour / Ainousah, Bayan E / Alorfi, Nasser M / Alghamdi, Alaa / Alqutub, Sulafa Tarek

International journal of general medicine

2023 Volume 16, Page(s) 3689–3699

Abstract: Introduction: The introduction of electronic prescription services has been a significant development in healthcare systems worldwide. In Saudi Arabia, the Wasfaty electronic prescription service was recently introduced, aiming to streamline ... ...

Abstract	Introduction: The introduction of electronic prescription services has been a significant development in healthcare systems worldwide. In Saudi Arabia, the Wasfaty electronic prescription service was recently introduced, aiming to streamline prescription transfer and medicine collection. Aim: This study assesses the implementation of Wasfaty by investigating prescription transfer, patient satisfaction, and medicine availability among beneficiaries at the University of Jeddah. Methods: A cross-sectional online questionnaire was distributed to students and staff at the University of Jeddah who had received e-prescriptions from the University Medical Centre (n = 2067) in July-December 2022. The questionnaire consisted of three sections: demographics, patient perceptions and satisfaction with the Wasfaty service, and the availability of prescribed medicines. A total of 217 completed questionnaires were received and analyzed. Results: Among the respondents, a majority were female (n = 125, 57.6%). A significant proportion of participants expressed satisfaction with the initial registration process of the Wasfaty service (n = 183, 84.1%). However, a noteworthy finding was that nearly one-third of the participants reported difficulties in locating their prescribed medicines (n = 64, 29.7%). Consequently, a majority of these individuals had to seek alternative pharmacies to obtain their prescribed treatment (n = 138, 63.9%). Of concern were reports of limited access to specific pharmaceuticals, such as anti-hypertensives and antidiabetic medications, which elicited dissatisfaction among respondents. Conclusion: This study sheds light on the challenges associated with the implementation of the Wasfaty electronic prescription service in Saudi Arabia. While initial registration satisfaction is notable, the study highlights issues concerning medicine availability and access to essential pharmaceuticals. Addressing these challenges requires the attention of service providers, and further investigation on a national scale is warranted to better understand and address these issues effectively.
Language	English
Publishing date	2023-08-22
Publishing country	New Zealand
Document type	Journal Article
ZDB-ID	2452220-X
ISSN	1178-7074
ISSN	1178-7074
DOI	10.2147/IJGM.S432075
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Article ; Online: Synchronous spectrofluorimetric determination of favipiravir and aspirin at the nano-gram scale in spiked human plasma; greenness evaluation.

Batubara, Afnan S / Ainousah, Bayan E / Ramzy, Sherif / Abdelazim, Ahmed H / Gamal, Mohammed / Tony, Rehab M

Spectrochimica acta. Part A, Molecular and biomolecular spectroscopy

2023 Volume 299, Page(s) 122880

Abstract: Favipiravir and aspirin are co-administered during COVID-19 treatment to prevent venous thromboembolism. For the first time, a spectrofluorometric method has been developed for the simultaneous analysis of favipiravir and aspirin in plasma matrix at nano- ...

Abstract	Favipiravir and aspirin are co-administered during COVID-19 treatment to prevent venous thromboembolism. For the first time, a spectrofluorometric method has been developed for the simultaneous analysis of favipiravir and aspirin in plasma matrix at nano-gram detection limits. The native fluorescence spectra of favipiravir and aspirin in ethanol showed overlapping emission spectra at 423 nm and 403 nm, respectively, after excitation at 368 nm and 298 nm, respectively. Direct simultaneous determination with normal fluorescence spectroscopy was difficult. The use of synchronous fluorescence spectroscopy for analyzing the studied drugs in ethanol at Δλ = 80 nm improved spectral resolution and enabled the determination of favipiravir and aspirin in the plasma matrix at 437 nm and 384 nm, respectively. The method described allowed sensitive determination of favipiravir and aspirin over a concentration range of 10-500 ng/mL and 35-1600 ng/mL, respectively. The described method was validated with respect to the ICH M10 guidelines and successfully applied for the simultaneous determination of the mentioned drugs in pure form and in the spiked plasma matrix. Moreover, the compliance of the method with the concepts of environmentally friendly analytical chemistry was evaluated using two metrics, the Green Analytical Procedure Index and the AGREE tool. The results showed that the described method was consistent with the accepted metrics for green analytical chemistry.
MeSH term(s)	Humans ; Spectrometry, Fluorescence/methods ; Aspirin ; COVID-19 Drug Treatment ; COVID-19 ; Ethanol
Chemical Substances	favipiravir (EW5GL2X7E0) ; Aspirin (R16CO5Y76E) ; Ethanol (3K9958V90M)
Language	English
Publishing date	2023-05-16
Publishing country	England
Document type	Journal Article
ZDB-ID	210413-1
ISSN	1873-3557 ; 0370-8322 ; 0584-8539 ; 1386-1425
ISSN (online)	1873-3557
ISSN	0370-8322 ; 0584-8539 ; 1386-1425
DOI	10.1016/j.saa.2023.122880
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Article ; Online: Green-adapted spectrophotometric determination of fostemsavir based on selective bromophenol blue extraction; reduction of hazardous consumption using computational calculations.

Batubara, Afnan S / Ainousah, Bayan E / Gamal, Mohammed / Almrasy, Ahmed A / Ramzy, Sherif / Ghoneim, Mohammed M / Abdelazim, Ahmed H

Scientific reports

2023 Volume 13, Issue 1, Page(s) 10049

Abstract: A computationally-assisted and green spectrophotometric method has been developed for the determination of fostemsavir, a recently FDA-approved drug used in combination with antiretroviral drugs to treat multidrug-resistant HIV-1 infection. The method ... ...

Abstract	A computationally-assisted and green spectrophotometric method has been developed for the determination of fostemsavir, a recently FDA-approved drug used in combination with antiretroviral drugs to treat multidrug-resistant HIV-1 infection. The method was developed using computational studies and solvent selection based on green chemistry principles. The density functional theory method was employed to identify bromophenol blue as the preferred acid dye for efficient extraction of fostemsavir. The solvent selection process involved a careful evaluation of the green ranking of solvents, which led to the use of water as the solvent. The method involved the extraction of fostemsavir with bromophenol blue to form a yellow ion-pair complex, which exhibited maximally sharp peaks at 418 nm, enabling sensitive visible spectrophotometric determination of fostemsavir in bulk and pharmaceutical preparations. The extraction procedures were optimized, and the method was demonstrated to be sensitive over the concentration range of 2-12 μg/mL fostemsavir. Furthermore, the method was evaluated with respect to green chemistry principles using the analytical eco-scale, the green analytical method index, and analytical greenness metric approach, all of which confirmed that the data obtained by the proposed method were environmentally acceptable.
MeSH term(s)	Bromphenol Blue ; Spectrophotometry/methods ; Organophosphates ; Solvents
Chemical Substances	Bromphenol Blue (0R2969YC90) ; fostemsavir (97IQ273H4L) ; Organophosphates ; Solvents
Language	English
Publishing date	2023-06-21
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2615211-3
ISSN	2045-2322 ; 2045-2322
ISSN (online)	2045-2322
ISSN	2045-2322
DOI	10.1038/s41598-023-36821-x
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Article ; Online: Exploring the potential of Aspergillus wentii: secondary metabolites and biological properties.

Ainousah, Bayan E / Ibrahim, Sabrin R M / Alzain, Abdulrahim A / Mohamed, Shaimaa G A / Hussein, Hazem G A / Ashour, Ahmed / Abdallah, Hossam M / Mohamed, Gamal A

Archives of microbiology

2024 Volume 206, Issue 5, Page(s) 216

Abstract: Fungi are of considerable importance due to their capacity to biosynthesize various secondary metabolites with bioactive properties that draw high attention in new drug discovery with beneficial uses for improving human well-being and life quality. ... ...

Abstract	Fungi are of considerable importance due to their capacity to biosynthesize various secondary metabolites with bioactive properties that draw high attention in new drug discovery with beneficial uses for improving human well-being and life quality. Aspergillus genus members are widespread and cosmopolitan species with varying economic significance in the fields of industry, medicine, and agriculture. Its species are renowned for their biosynthesis of secondary metabolites, characterized by both potent biological activity and structural novelty, making them a substantial reservoir for the development of new pharmaceuticals. The current work aimed at focusing on one species of this genus, Aspergillus wentii Wehmer, including its reported secondary metabolites in the period from 1951 to November 2023. A total of 97 compounds, including nitro-compounds, terpenoids, anthraquinones, xanthones, benzamides, and glucans. A summary of their bioactivities, as well as their biosynthesis was highlighted. Additionally, the reported applications of this fungus and its enzymes have been discussed. This review offers a useful reference that can direct future research into this fungus and its active metabolites, as well as their possible pharmacological and biotechnological applications.
MeSH term(s)	Humans ; Aspergillus ; Agriculture ; Anthraquinones/pharmacology ; Benzamides
Chemical Substances	Anthraquinones ; Benzamides
Language	English
Publishing date	2024-04-15
Publishing country	Germany
Document type	Journal Article ; Review
ZDB-ID	124824-8
ISSN	1432-072X ; 0302-8933
ISSN (online)	1432-072X
ISSN	0302-8933
DOI	10.1007/s00203-024-03934-4
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Article: Tetraenone A: A New β-Ionone Derivative from

Ashour, Ahmed / Sherif, Asmaa E / El-Sayed, Selwan M / Kim, Ji-Young / Jang, Dae Sik / Anvari, Abtin / Farahat, Abdelbasset A / Ibrahim, Sabrin R M / Mohamed, Gamal A / Ainousah, Bayan E / Aljohani, Raghad F / Al-Hejaili, Razan R / Khoja, Rahaf H / Hassan, Ahmed H E / Zaki, Ahmed A

Metabolites

2023 Volume 13, Issue 12

Abstract: In this study, the chemical investigation ... ...

Abstract	In this study, the chemical investigation of
Language	English
Publishing date	2023-12-18
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2662251-8
ISSN	2218-1989
ISSN	2218-1989
DOI	10.3390/metabo13121202
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Article: Potential Therapeutic Target and Vaccines for SARS-CoV-2.

Hussain, Mohamed A / Hassan, Mohamed M / Bashir, Bashir Abdrhman / Gamar, Tarig A / Gasmalbari, Elmuaiz / Mohamed, Ahmed Osman / Osman, Wadah / Sherif, Asmaa E / Elgaml, Abdelaziz / Alhaddad, Aisha A / Ghazawi, Kholoud F / Miski, Samar F / Ainousah, Bayan E / Andijani, Yusra Saleh / Ibrahim, Sabrin R M / Mohamed, Gamal A / Ashour, Ahmed

Pathogens (Basel, Switzerland)

2023 Volume 12, Issue 7

Abstract: The coronavirus has become the most interesting virus for scientists because of the recently emerging deadly SARS-CoV-2. This study aimed to understand the behavior of SARS-CoV-2 through the comparative genomic analysis with the closest one among the ... ...

Abstract	The coronavirus has become the most interesting virus for scientists because of the recently emerging deadly SARS-CoV-2. This study aimed to understand the behavior of SARS-CoV-2 through the comparative genomic analysis with the closest one among the seven species of coronavirus that infect humans. The genomes of coronavirus species that infect humans were retrieved from NCBI, and then subjected to comparative genomic analysis using different bioinformatics tools. The study revealed that SARS-CoV-2 is the most similar to SARS-CoV among the coronavirus species. The core genes were shared by the two genomes, but there were some genes, found in one of them but not in both, such as ORF8, which is found in SARS-CoV-2. The ORF8 protein of SARS-CoV-2 could be considered as a good therapeutic target for stopping viral transmission, as it was predicted to be a transmembrane protein, which is responsible for interspecies transmission. This is supported by the molecular interaction of ORF8 with both the ORF7 protein, which contains a transmembrane domain that is essential to retaining the protein in the Golgi compartment, and the S protein, which facilitates the entry of the coronavirus into host cells. ORF1ab, ORF1a, ORF8, and S proteins of SARS-CoV-2 could be immunogenic and capable of evoking an immune response, which means that these four proteins could be considered a potential vaccine source. Overall, SARS-CoV-2 is most related to SARS-CoV. ORF8 could be considered a potential therapeutic target for stopping viral transmission, and ORF1ab, ORF1a, ORF8, and the S proteins of SARS-CoV-2 could be utilized as a potential vaccine source.
Language	English
Publishing date	2023-07-10
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2695572-6
ISSN	2076-0817
ISSN	2076-0817
DOI	10.3390/pathogens12070926
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Article ; Online: Design of new Mcl-1 inhibitors for cancer using fragments hybridization, molecular docking, and molecular dynamics studies.

Alzain, Abdulrahim A / Elbadwi, Fatima A / Mukhtar, Rua M / Shoaib, Tagyedeen H / Abdelmoniem, Nihal / Miski, Samar F / Ghazawi, Kholoud F / Alsulaimany, Marwa / Mohamed, Shaimaa G A / Ainousah, Bayan E / Hussein, Hazem G A / Mohamed, Gamal A / Ibrahim, Sabrin R M

Journal of biomolecular structure & dynamics

2023 , Page(s) 1–13

Abstract: Apoptosis is a critical process that regulates cell survival and death and plays an essential role in cancer development. The Bcl-2 protein family, including myeloid leukemia 1 (Mcl-1), is a key regulator of the intrinsic apoptosis pathway, and its ... ...

Abstract	Apoptosis is a critical process that regulates cell survival and death and plays an essential role in cancer development. The Bcl-2 protein family, including myeloid leukemia 1 (Mcl-1), is a key regulator of the intrinsic apoptosis pathway, and its overexpression in many human cancers has prompted efforts to develop Mcl-1 inhibitors as potential anticancer agents. In this study, we aimed to design new Mcl-1 inhibitors using various computational techniques. First, we used the Mcl-1 receptor-ligand complex to build an e-pharmacophore hypothesis and screened a library of 567,000 fragments from the Enamine database. We obtained 410 fragments and used them to design 92,384 novel compounds, which we then docked into the Mcl-1 binding cavity using HTVS, SP, and XP docking modes of Glide. To assess their suitability as drug candidates, we conducted MM-GBSA calculations and ADME prediction, leading to the identification of 10 compounds with excellent binding affinity and favorable pharmacokinetic properties. To further investigate the interaction strength, we performed molecular dynamics simulations on the top three Mcl-1 receptor-ligand complexes to study their interaction stability. Overall, our findings suggest that these compounds have promising potential as anticancer agents, pending further experimental validation such as Mcl-1 apoptosis Assay. By combining experimental methods with various
Language	English
Publishing date	2023-11-14
Publishing country	England
Document type	Journal Article
ZDB-ID	49157-3
ISSN	1538-0254 ; 0739-1102
ISSN (online)	1538-0254
ISSN	0739-1102
DOI	10.1080/07391102.2023.2281637
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Article ; Online: Dual Level Statistical Investigation of Equilibrium Solubility in Simulated Fasted and Fed Intestinal Fluid.

Ainousah, Bayan E / Perrier, Jeremy / Dunn, Claire / Khadra, Ibrahim / Wilson, Clive G / Halbert, Gavin

Molecular pharmaceutics

2017 Volume 14, Issue 12, Page(s) 4170–4180

Abstract: The oral route is the preferred option for drug administration but contains the inherent issue of drug absorption from the gastro-intestinal tract (GIT) in order to elicit systemic activity. A prerequisite for absorption is drug dissolution, which is ... ...

Abstract	The oral route is the preferred option for drug administration but contains the inherent issue of drug absorption from the gastro-intestinal tract (GIT) in order to elicit systemic activity. A prerequisite for absorption is drug dissolution, which is dependent upon drug solubility in the variable milieu of GIT fluid, with poorly soluble drugs presenting a formulation and biopharmaceutical challenge. Multiple factors within GIT fluid influence solubility ranging from pH to the concentration and ratio of amphiphilic substances, such as phospholipid, bile salt, monoglyceride, and cholesterol. To aid in vitro investigation simulated intestinal fluids (SIF) covering the fasted and fed state have been developed. SIF media is complex and statistical design of experiment (DoE) investigations have revealed the range of solubility values possible within each state due to physiological variability along with the media factors and factor interactions which influence solubility. However, these studies require large numbers of experiments (>60) and are not feasible or sensible within a drug development setting. In the current study a smaller dual level, reduced experimental number (20) DoE providing three arms covering the fasted and fed states along with a combined analysis has been investigated. The results indicate that this small scale investigation is feasible and provides solubility ranges that encompass published data in human and simulated fasted and fed fluids. The measured fasted and fed solubility ranges are in agreement with published large scale DoE results in around half of the cases, with the differences due to changes in media composition between studies. Indicating that drug specific behaviors are being determined and that careful media factor and concentration level selection is required in order to determine a physiologically relevant solubility range. The study also correctly identifies the major single factor or factors which influence solubility but it is evident that lower significance factors (for example bile salt) are not picked up due to the lower sample number employed. A similar issue is present with factor interactions with only a limited number available for study and generally not determined to have a significant solubility impact due to the lower statistical power of the study. The study indicates that a reduced experimental number DoE is feasible, will provide solubility range results with identification of major solubility factors however statistical limitations restrict the analysis. The approach therefore represents a useful initial screening tool that can guide further in depth analysis of a drug's behavior in gastrointestinal fluids.
MeSH term(s)	Administration, Oral ; Body Fluids/chemistry ; Body Fluids/physiology ; Fasting/physiology ; Feasibility Studies ; Humans ; Hydrogen-Ion Concentration ; In Vitro Techniques/methods ; Intestinal Absorption/physiology ; Intestines/chemistry ; Intestines/physiology ; Pharmaceutical Preparations/administration & dosage ; Pharmaceutical Preparations/chemistry ; Solubility
Chemical Substances	Pharmaceutical Preparations
Language	English
Publishing date	2017-11-15
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2138405-8
ISSN	1543-8392 ; 1543-8384
ISSN (online)	1543-8392
ISSN	1543-8384
DOI	10.1021/acs.molpharmaceut.7b00869
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