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Article ; Online: Optimization of apigenin nanoparticles prepared by planetary ball milling

Alshehri Abdulla Ali / Ibrahim Mohamed Abbas / Alshehri Sultan Mohamed / Alshora Doaa / Elzayat Ehab Mostafa / Almeanazel Osaid / Alsaadi Badr / El Sherbiny Gamal A. / Osman Shaaban Khalaf

Green Processing and Synthesis, Vol 12, Iss 1, Pp 237-

In vitro and in vivo studies

2023 Volume 43

Abstract: This study intended to optimize apigenin (APG) nanoparticle formulation prepared by planetary ball milling to enhance its dissolution rate and bioavailability using a design of experiment (DoE). In this study, polyvinyl pyrrolidone (PVP K30) was used as ... ...

Abstract	This study intended to optimize apigenin (APG) nanoparticle formulation prepared by planetary ball milling to enhance its dissolution rate and bioavailability using a design of experiment (DoE). In this study, polyvinyl pyrrolidone (PVP K30) was used as a nanoparticle stabilizer. The independent parameters of milling speed, milling ball size, and drug to solvent ratio were evaluated for their impacts on APG nanoparticles concerning the nanoparticle size (Y1), zeta potential (Y2), and drug dissolution efficiency after 60 min, notated as % DE60 (Y3). The milling ball size showed a significant antagonistic effect (P = 0.0210) on the size of APG nanoparticles, while milling speed had an agonistic effect on the zeta potential values of drug nanoparticles, ranging from low to medium speed levels. In addition, ANOVA analysis indicated that the effect of the drug-to-solvent ratio on the % DE60 of APG from the nanoparticle formulations was antagonistically significant (P = 0.015), and the quadratic effect of milling speed (AA) also had a significant antagonistic effect (P = 0.025) on the % DE60. Risk assessment analytical tools revealed that milling ball size and milling speed significantly affect the nanoparticle size. The drug/solvent ratio exerted a strong impact on % DE60. Furthermore, the maximum plasma concentration (C max) of the optimized APG nanoparticle formula increased by four folds. In addition, AUC0–t (ng·mL−1·h−1) for APG nanoparticle (353.7 ± 185.3 ng·mL−1·h−1) was higher than that noticed in the case of the untreated drug (149 ± 137.5 ng·mL−1·h−1) by more than two folds.
Keywords	apigenin ; optimization ; nanonization ; planetary ball milling ; pharmacokinetics ; Chemistry ; QD1-999
Subject code	500
Language	English
Publishing date	2023-02-01T00:00:00Z
Publisher	De Gruyter
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article: Formulation of sublingual promethazine hydrochloride tablets for rapid relief of motion sickness.

Alyami, Hamad S / Ibrahim, Mohamed A / Alyami, Mohammad H / Dahmash, Eman Z / Almeanazel, Osaid T / Algahtani, Thamer S / Alanazi, Fars / Alshora, Doaa H

Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society

2021 Volume 29, Issue 5, Page(s) 478–486

Abstract: The delivery of antihistaminic agents via the oral route is problematic, especially for elderly patients. This study aimed to develop a sublingual formulation of promethazine hydrochloride by direct compression, and to mask its intensely bitter taste. ... ...

Abstract	The delivery of antihistaminic agents via the oral route is problematic, especially for elderly patients. This study aimed to develop a sublingual formulation of promethazine hydrochloride by direct compression, and to mask its intensely bitter taste. Promethazine hydrochloride (PMZ) sublingual tablets prepared by direct compression were optimized using Box-Behnken full factorial design. The effect of a taste-masking agent (Eudragit E 100, X1), superdisintegrant (crospovidone; CPV, X2) and lubricant (sodium stearyl fumarate; SSF, X3) on sublingual tablets' attributes (responses, Y) was optimized. The prepared sublingual tablets were characterized for hardness (Y1), disintegration time (Y2), initial dissolution rate (IDR; Y3) and dissolution efficiency after 30 min (Dissolution Efficiency (DE); Y4). The obtained results showed a significant positive effect of the three independent factors on tablet hardness (P < 0.05), and the interactive effect of Eudragit E 100 and CPV on tablet hardness was significant. Disintegration time was mainly affected by Eudragit E 100 and CPV concentrations. Moreover, IDR was employed to assess the taste masking effect, lower values were obtained at higher Eudragit E 100 concentration despite it was statistically insignificant (p > 0.05). Optimized formulation that was suggested by the software was composed of: Eudragit E 100 (X1) = 2.5% w/w, CPV (X2) = 4.13% w/w, and SSF (X3) = 1.0% w/w. The observed values of the optimized formula were found to be close to the predicted optimized values. The Differential Scanning Calorimetric (DSC) studies indicated no interaction between PMZ and tablet excipients.
Language	English
Publishing date	2021-04-23
Publishing country	Saudi Arabia
Document type	Journal Article
ZDB-ID	1378024-4
ISSN	1319-0164
ISSN	1319-0164
DOI	10.1016/j.jsps.2021.04.011
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Article ; Online: Defining the process parameters affecting the fabrication of rosuvastatin calcium nanoparticles by planetary ball mill.

Alshora, Doaa / Ibrahim, Mohamed / Elzayat, Ehab / Almeanazel, Osaid T / Alanazi, Fars

International journal of nanomedicine

2019 Volume 14, Page(s) 4625–4636

Abstract: Purpose: Rosuvastatin calcium (ROSCa) nanoparticles were fabricated by planetary ball mill to enhance ROSCa dissolution rate and bioavailability.: Methods: Milling time factors (milling cycle time and number as well as pause time) were explored. The ... ...

Abstract	Purpose: Rosuvastatin calcium (ROSCa) nanoparticles were fabricated by planetary ball mill to enhance ROSCa dissolution rate and bioavailability. Methods: Milling time factors (milling cycle time and number as well as pause time) were explored. The effect of different milling ball size, speed, and solid-to-solvent ratio were also studied using Box-Behnken factorial design. The fabricated nanoparticles were evaluated in term of physicochemical properties and long-term stability. Results: The obtained data revealed that the integrated formulation and process factors should be monitored to obtain desirable nanoparticle attributes in terms of particle size, zeta potential, dissolution rate, and bioavailability. The optimized ROSCa nanoparticles prepared by milling technique showed a significant enhancement in the dissolution rate by 1.3-fold and the plasma concentration increased by 2-fold ( Conclusion: Formulation of ROSCa as nanoparticles using milling technique showed a significant enhancement in both dissolution rate and plasma concentration as well as stability compared with untreated drug.
MeSH term(s)	Animals ; Drug Stability ; Nanoparticles/chemistry ; Nanoparticles/ultrastructure ; Nanotechnology/methods ; Particle Size ; Rabbits ; Rosuvastatin Calcium/blood ; Rosuvastatin Calcium/chemistry ; Rosuvastatin Calcium/pharmacokinetics ; Static Electricity ; Time Factors
Chemical Substances	Rosuvastatin Calcium (83MVU38M7Q)
Language	English
Publishing date	2019-06-27
Publishing country	New Zealand
Document type	Journal Article
ZDB-ID	2364941-0
ISSN	1178-2013 ; 1176-9114
ISSN (online)	1178-2013
ISSN	1176-9114
DOI	10.2147/IJN.S207301
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Article: Nanotechnology as a tool to overcome the bariatric surgery malabsorption.

Almeanazel, Osaid / Alanazi, Fars / Alsarra, Ibrahim / Alshora, Doaa / Shakeel, Faiyaz / Almnaizel, Ahmad / Alahmed, Mohammed / Fouad, Ehab

Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society

2020 Volume 28, Issue 5, Page(s) 565–573

Abstract: Obesity is a metabolic disease that affects all ages; it is considered life-threatening condition as it leads to fatal complications such as; cardiovascular diseases and diabetes. The therapeutic options include; life-style modifications, pharmacotherapy ...

Abstract	Obesity is a metabolic disease that affects all ages; it is considered life-threatening condition as it leads to fatal complications such as; cardiovascular diseases and diabetes. The therapeutic options include; life-style modifications, pharmacotherapy intervention, and surgical intervention. Bariatric surgery (BS) is considered as the most effective option among the others for its rapid weight loss, maintaining the lost mass, and improving the quality of life of the patients. Nevertheless, BS leads to severe changes in the bioavailability of medications, especially for chronic diseases, which may reach to limit where the patient's life endangers. Recently, pharmaceutical formulations had developed several methods to improve the drug bioavailability of drugs though the implying of nanotechnology. Nonotechnology is responsible for reducing the size of the drugs to the nano range (<1000 nm), which increase the drug surface area, dissolution, absorption, and, most importantly, the bioavailability of these drugs. It is believed that BS malabsorption and drugs bioavailability problems can be solved using nanotechnology for its advantages in overcoming BS complications.
Language	English
Publishing date	2020-03-19
Publishing country	Saudi Arabia
Document type	Journal Article ; Review
ZDB-ID	1378024-4
ISSN	1319-0164
ISSN	1319-0164
DOI	10.1016/j.jsps.2020.03.008
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Article ; Online: Co-stabilization of pioglitazone HCL nanoparticles prepared by planetary ball milling:

Alshora, Doaa H / Alsaif, Shaikha / Ibrahim, Mohamed A / Ezzeldin, Essam / Almeanazel, Osaid T / Abou El Ela, Amal El Sayeh / Ashri, Lubna Y

Pharmaceutical development and technology

2020 Volume 25, Issue 7, Page(s) 845–854

Abstract: Pioglitazone (PGZ) is an oral antidiabetic agent that increases cell resistance to insulin, thereby decreasing blood glucose levels. PGZ is a class II drug. Because of its pH-dependent solubility, it precipitates at the intestinal pH, resulting in an ... ...

Abstract	Pioglitazone (PGZ) is an oral antidiabetic agent that increases cell resistance to insulin, thereby decreasing blood glucose levels. PGZ is a class II drug. Because of its pH-dependent solubility, it precipitates at the intestinal pH, resulting in an erratic and incomplete absorption following oral administration, which causes fluctuations in its plasma concentration. A nanoparticle drug delivery system offers a solution to enhance the dissolution rate of this poorly water-soluble drug. PGZ nanoparticles were formulated by the wet milling technique using a planetary ball mill. The effects of the steric stabilizer (Pluronic F-127, PL F-127), electrostatic stabilizer (sodium deoxycholate, SDC), and number of milling cycles were optimized using a Box-Behnken factorial design. The results showed that the ratio of PL F-127: SDC significantly affected the zeta potential and the dissolution efficiency (DE%) of PGZ. The optimized PGZ nanoparticle formulation enhanced the dissolution to reach 100% after 5 min. The
MeSH term(s)	Animals ; Chemistry, Pharmaceutical/methods ; Drug Evaluation, Preclinical/methods ; Drug Stability ; Hypoglycemic Agents/chemical synthesis ; Hypoglycemic Agents/pharmacokinetics ; Male ; Nanoparticles/chemistry ; Nanoparticles/metabolism ; Pioglitazone/chemical synthesis ; Pioglitazone/pharmacokinetics ; Random Allocation ; Rats ; Rats, Wistar ; X-Ray Diffraction/methods
Chemical Substances	Hypoglycemic Agents ; Pioglitazone (X4OV71U42S)
Language	English
Publishing date	2020-03-23
Publishing country	England
Document type	Journal Article
ZDB-ID	1331774-x
ISSN	1097-9867 ; 1083-7450
ISSN (online)	1097-9867
ISSN	1083-7450
DOI	10.1080/10837450.2020.1744163
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Zs.A 5043: Show issues

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Article ; Online: Rosuvastatin calcium nanoparticles: Improving bioavailability by formulation and stabilization codesign.

Alshora, Doaa H / Ibrahim, Mohamed A / Elzayat, Ehab / Almeanazel, Osaid T / Alanazi, Fars

PloS one

2018 Volume 13, Issue 7, Page(s) e0200218

Abstract: Purpose: Rosuvastatin calcium (ROSCa) is a poorly soluble drug with bioavailability not exceeding 20%. Decreasing the particle size may enhance its solubility, dissolution rate and bioavailability. Therefore, the aim of the current study is to prepare ... ...

Abstract	Purpose: Rosuvastatin calcium (ROSCa) is a poorly soluble drug with bioavailability not exceeding 20%. Decreasing the particle size may enhance its solubility, dissolution rate and bioavailability. Therefore, the aim of the current study is to prepare ROSCa nanoparticles by wet milling technique using planetary ball mill. The codesign between formulation and stabilization of nanoparticles was studied to achieve both high dissolution as well as bioavailability. Methodology: ROSCa nanosuspensions was prepared by wet milling technique using planetary ball mill, by applying milling ball size of 0.1 mm at speed of 800 rpm for 3 cycles each cycle composed of 10 minutes. HPMC, PVP k-30, pluronic F-127, Tween 80 and PEG 6000 were used as stabilizers. The nanosuspensions were then freeze-dried, and the dried nanoparticles were evaluated for particle size, zeta potential, in-vitro dissolution test, XRPD and in-vivo study. Results: ROSCa nanoparticles stabilized with 10% PVP (P3) had a good stability with smallest particle size, which in turn enhanced the dissolution rate. The particle size of the leading formula was 461.8 ± 16.68 nm with zeta potential of -31.8 ± 7.22 mV compared to untreated drug that has a particle size of 618μm. The percent of ROSCa dissolved after 1 hour enhanced significantly which reached 72% and 58.25% for leading nanoparticle formula and untreated ROSCa, respectively (P < 0.05). The in-vivo study of ROSCa from the leading nanoparticle formula showed a significant enhancement in the Cmax after 2 h (82.35 ng/ml) compared to 9.2 ng/ml for untreated drug. Conclusion: Wet milling technique is a successful method to prepare ROSCa nanoparticles. From different stabilizer used, PVP (10%) was able to produce stable nanoparticle with small particle size which significantly enhance the dissolution rate and pharmacokinetics parameters of ROSCa.
MeSH term(s)	Animals ; Anticholesteremic Agents/chemistry ; Anticholesteremic Agents/pharmacokinetics ; Biological Availability ; Drug Compounding ; Drug Design ; Nanoparticles/chemistry ; Particle Size ; Rabbits ; Rosuvastatin Calcium/chemistry ; Rosuvastatin Calcium/pharmacokinetics
Chemical Substances	Anticholesteremic Agents ; Rosuvastatin Calcium (83MVU38M7Q)
Language	English
Publishing date	2018-07-09
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ISSN	1932-6203
ISSN (online)	1932-6203
DOI	10.1371/journal.pone.0200218
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Rat palatability, pharmacodynamics effect and bioavailability of mefenamic acid formulations utilizing hot-melt extrusion technology.

Alshehri, Sultan / Shakeel, Faiyaz / Elzayat, Ehab / Almeanazel, Osaid / Altamimi, Mohammad / Shazly, Gamal / Kazi, Mohsin / Almutairy, Bjad / Alsulays, Bader / Alshetaili, Abdullah / Alalaiwe, Ahmed / Repka, Michael

Drug development and industrial pharmacy

2019 Volume 45, Issue 10, Page(s) 1610–1616

Abstract: Mefenamic acid (MA) has been reported as a weakly soluble drug which presents ... ...

Abstract	Mefenamic acid (MA) has been reported as a weakly soluble drug which presents weak
MeSH term(s)	Animals ; Anti-Inflammatory Agents/chemistry ; Anti-Inflammatory Agents/metabolism ; Anti-Inflammatory Agents/pharmacology ; Biological Availability ; Calorimetry, Differential Scanning/methods ; Chemistry, Pharmaceutical/methods ; Drug Carriers/chemistry ; Drug Compounding/methods ; Female ; Hot Melt Extrusion Technology/methods ; Inflammation/drug therapy ; Mefenamic Acid/chemistry ; Mefenamic Acid/metabolism ; Mefenamic Acid/pharmacology ; Rats ; Rats, Wistar ; Solubility/drug effects
Chemical Substances	Anti-Inflammatory Agents ; Drug Carriers ; Mefenamic Acid (367589PJ2C)
Language	English
Publishing date	2019-07-29
Publishing country	England
Document type	Journal Article
ZDB-ID	751874-2
ISSN	1520-5762 ; 0363-9045
ISSN (online)	1520-5762
ISSN	0363-9045
DOI	10.1080/03639045.2019.1645161
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Article: Dissolution and bioavailability improvement of bioactive apigenin using solid dispersions prepared by different techniques.

Alshehri, Sultan M / Shakeel, Faiyaz / Ibrahim, Mohamed A / Elzayat, Ehab M / Altamimi, Mohammad / Mohsin, Kazi / Almeanazel, Osaid T / Alkholief, Musaed / Alshetaili, Abdullah / Alsulays, Bader / Alanazi, Fars K / Alsarra, Ibrahim A

Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society

2018 Volume 27, Issue 2, Page(s) 264–273

Abstract: Apigenin (APG) is a poorly soluble bioactive compound/nutraceutical which shows poor bioavailability upon oral administration. Hence, the objective of this research work was to develop APG solid dispersions (SDs) using different techniques with the ... ...

Abstract	Apigenin (APG) is a poorly soluble bioactive compound/nutraceutical which shows poor bioavailability upon oral administration. Hence, the objective of this research work was to develop APG solid dispersions (SDs) using different techniques with the expectation to obtain improvement in its in vitro dissolution rate and in vivo bioavailability upon oral administration. Different SDs of APG were prepared by microwave, melted and kneaded technology using pluronic-F127 (PL) as a carrier. Prepared SDs were characterized using "thermogravimetric analysis (TGA), differential scanning calorimetry (DSC), Fourier transform infra-red (FTIR) spectrometer, powder X-ray diffraction (PXRD) and scanning electron microscopy (SEM)". After characterization, prepared SDs of APG were studied for in vitro drug release/dissolution profile and in vivo pharmacokinetic studies. The results of TGA, DSC, FTIR, PXRD and SEM indicated successful formation of APG SDs. In vitro dissolution experiments suggested significant release of APG from all SDs (67.39-84.13%) in comparison with control (32.74%). Optimized SD of APG from each technology was subjected to in vivo pharmacokinetic study in rats. The results indicated significant improvement in oral absorption of APG from SD prepared using microwave and melted technology in comparison with pure drug and commercial capsule. The enhancement in oral bioavailability of APG from microwave SD (319.19%) was 3.19 fold as compared with marketed capsule (100.00%). Significant enhancement in the dissolution rate and oral absorption of APG from SD suggested that developed SD systems can be successfully used for oral drug delivery system of APG.
Language	English
Publishing date	2018-11-14
Publishing country	Saudi Arabia
Document type	Journal Article
ZDB-ID	1378024-4
ISSN	1319-0164
ISSN	1319-0164
DOI	10.1016/j.jsps.2018.11.008
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