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Article ; Online: Comparative Bioavailability Study of Solid Self-Nanoemulsifying Drug Delivery System of Fenofibric Acid in Healthy Male Subjects.

Suhery, Wira Noviana / Mudhakir, Diky / Sumirtapura, Yeyet Cahyati / Pamudji, Jessie Sofia

Medical principles and practice : international journal of the Kuwait University, Health Science Centre

2022 Volume 31, Issue 2, Page(s) 142–148

Abstract: Objective: This study aimed to evaluate the effect of solid self-nanoemulsifying drug delivery system (S-SNEDDS) formation on the bioavailability of fenofibric acid.: Subject and methods: Three formulations of fenofibric acid, namely, S-SNEDDS ... ...

Abstract	Objective: This study aimed to evaluate the effect of solid self-nanoemulsifying drug delivery system (S-SNEDDS) formation on the bioavailability of fenofibric acid. Subject and methods: Three formulations of fenofibric acid, namely, S-SNEDDS containing medium-chain triglyceride (FS1), S-SNEDDS containing long-chain triglyceride (FS2), and FSt as tablet of innovator product, were used in this study. Bioavailability study was conducted in 12 Indonesian healthy male subjects after a single-dose administration of each formulation with three-way crossover design. Blood samples were collected from 0 to 72 h after drug administration and then analyzed using the high-performance liquid chromatography method. Data were statistically analyzed using the ANOVA and the Wilcoxon signed-rank test using a p value of 0.05. Dissolution test was carried out with USP dissolution apparatus using three medium (pH 1.2, 4.5 and 6.8). Results: The rates of absorption of fenofibric acid from S-SNEDDS FS1 and FS2 were significantly increased about 1.78 and 2.40 times, respectively, relative to FSt. Tmax values of FS1 and FS2 were shorter than FSt, namely, 0.96 ± 0.438 h (FS1), 0.71 ± 0.445 h (FS2), and 1.71 ± 0.840 h (FSt), respectively. Meanwhile, the Cmax and AUC values of FS1, FS2, and FSt were found to be not significantly different with a p value of >0.05. S-SNEDDS formation increased the dissolution rate in acid medium. Conclusions: S-SNEDDS increased the dissolution rate in acid medium and absorption rate of fenofibric acid but did not increase the extent of fenofibric acid absorption.
MeSH term(s)	Administration, Oral ; Biological Availability ; Drug Delivery Systems/methods ; Emulsions ; Fenofibrate/analogs & derivatives ; Humans ; Male ; Nanoparticles/chemistry ; Particle Size ; Solubility ; Triglycerides
Chemical Substances	Emulsions ; Triglycerides ; fenofibric acid (BGF9MN2HU1) ; Fenofibrate (U202363UOS)
Language	English
Publishing date	2022-02-08
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	645108-1
ISSN	1423-0151 ; 1011-7571
ISSN (online)	1423-0151
ISSN	1011-7571
DOI	10.1159/000522380
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Zs.A 2486: Show issues

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Article: Synthesis, characterization, and stability study of desloratadine multicomponent crystal formation.

Ainurofiq, Ahmad / Mauludin, Rachmat / Mudhakir, Diky / Soewandhi, Sundani Nurono

Research in pharmaceutical sciences

2018 Volume 13, Issue 2, Page(s) 93–102

Abstract: This study describes the formation of multicomponent crystal (MCC) of desloratadine (DES). The objective of this study was to discover the new pharmaceutical MCC of DES using several coformers. The MCC synthesis was performed between DES and 26 coformers ...

Abstract	This study describes the formation of multicomponent crystal (MCC) of desloratadine (DES). The objective of this study was to discover the new pharmaceutical MCC of DES using several coformers. The MCC synthesis was performed between DES and 26 coformers using an equimolar ratio with a solvent evaporation technique. The selection of the appropriate solvent was carried out using 12 solvents. The preview of the MCC of DES was performed using polarized light microscopy (PLM). The formation of MCC was confirmed using powder X-ray diffraction (PXRD), differential scanning calorimetry (DSC), fourier transform infrared spectroscopy (FTIR), and scanning electron microscopy (SEM). The accelerated stability of MCC at 40 °C and relative humidity of 75% was investigated using PXRD and FTIR. Depending on the prior evaluation, DES and benzoic acid (BA) formed the MCC. PLM and SEM results showed that crystal habit of combination between DES and BA differed from the constituent components. Moreover, the diffractogram pattern of DES-BA was distinct from the constituent components. The DSC thermogram showed a new peak which was distinct from both constituent components. The FTIR study proved a new spectrum. All characterizations indicated that a new solid crystal was formed, ensuring the MCC formation. In addition, DES-BA MCC had both chemical and physical stabilities for a period of 4 months.
Language	English
Publishing date	2018-02-15
Publishing country	Iran
Document type	Journal Article
ZDB-ID	2400156-9
ISSN	1735-9414 ; 1735-5362
ISSN (online)	1735-9414
ISSN	1735-5362
DOI	10.4103/1735-5362.223775
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Article: A Novel Desloratadine-Benzoic Acid Co-Amorphous Solid: Preparation, Characterization, and Stability Evaluation.

Ainurofiq, Ahmad / Mauludin, Rachmat / Mudhakir, Diky / Soewandhi, Sundani Nurono

Pharmaceutics

2018 Volume 10, Issue 3

Abstract: Low physical stability is the limitation of the widespread use of amorphous drugs. The co-amorphous drug system is a new and emerging method for preparing a stable amorphous form. Co-amorphous is a single-phase amorphous multicomponent system consisting ... ...

Abstract	Low physical stability is the limitation of the widespread use of amorphous drugs. The co-amorphous drug system is a new and emerging method for preparing a stable amorphous form. Co-amorphous is a single-phase amorphous multicomponent system consisting of two or more small molecules that are a combination of drugs or drugs and excipients. The co-amorphous system that uses benzoic acid (BA) as an excipient was studied to improve the physical stability, dissolution, and solubility of desloratadine (DES). In this study, the co-amorphous formation of DES and BA (DES⁻BA) was prepared by melt-quenching method and characterized by differential scanning calorimetry (DSC), Fourier transform infrared spectroscopy (FTIR), powder X-ray diffraction (PXRD), and polarized light microscopy (PLM). Dissolution, solubility, and physical stability profiles of DES⁻BA were determined. The DES crystals were converted into DES⁻BA co-amorphous form to reveal the molecular interactions between DES and BA. Solid-state analysis proved that the co-amorphous DES⁻BA system (1:1) is amorphous and homogeneous. The DSC experiment showed that the glass transition temperature (Tg) of tested DES⁻BA co-amorphous had a higher single Tg compared to the amorphous DES. FTIR revealed strong interactions, especially salt formation. The dissolution rate and solubility of co-amorphous DES⁻BA (1:1) obtained were larger than the DES in crystalline form. The PXRD technique was used to assess physical stability for three months at 40 °C with 75% RH. The DES⁻BA co-amorphous system demonstrated better physical stability than a single form of amorphous DES. Co-amorphous DES⁻BA has demonstrated the potential for improving solid-state stability, as the formation of DES⁻BA co-amorphous salt increased solubility and dissolution when compared to pure crystalline DES. This study also demonstrated the possibility for developing a DES⁻BA co-amorphous system toward oral formulations to improve DES solubility and bioavailability.
Language	English
Publishing date	2018-07-06
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2527217-2
ISSN	1999-4923
ISSN	1999-4923
DOI	10.3390/pharmaceutics10030085
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Article ; Online: Infectious Disease Modeling with Socio-Viral Behavioral Aspects-Lessons Learned from the Spread of SARS-CoV-2 in a University.

Nuraini, Nuning / Sukandar, Kamal Khairudin / Tahu, Maria Yulita Trida / Giri-Rachman, Ernawati Arifin / Barlian, Anggraini / Suhardi, Sri Harjati / Pasaribu, Udjianna Sekteria / Yuliar, Sonny / Mudhakir, Diky / Ariesyady, Herto Dwi / Rosleine, Dian / Sofyan, Iyan / Martokusumo, Widjaja

Tropical medicine and infectious disease

2022 Volume 7, Issue 10

Abstract: When it comes to understanding the spread of COVID-19, recent studies have shown that pathogens can be transmitted in two ways: direct contact and airborne pathogens. While the former is strongly related to the distancing behavior of people in society, ... ...

Abstract	When it comes to understanding the spread of COVID-19, recent studies have shown that pathogens can be transmitted in two ways: direct contact and airborne pathogens. While the former is strongly related to the distancing behavior of people in society, the latter are associated with the length of the period in which the airborne pathogens remain active. Considering those facts, we constructed a compartmental model with a time-dependent transmission rate that incorporates the two sources of infection. This paper provides an analytical and numerical study of the model that validates trivial insights related to disease spread in a responsive society. As a case study, we applied the model to the COVID-19 spread data from a university environment, namely, the Institut Teknologi Bandung, Indonesia, during its early reopening stage, with a constant number of students. The results show a significant fit between the rendered model and the recorded cases of infections. The extrapolated trajectories indicate the resurgence of cases as students' interaction distance approaches its natural level. The assessment of several strategies is undertaken in this study in order to assist with the school reopening process.
Language	English
Publishing date	2022-10-09
Publishing country	Switzerland
Document type	Journal Article
ISSN	2414-6366
ISSN (online)	2414-6366
DOI	10.3390/tropicalmed7100289
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Article ; Online: Learning from the viral journey: how to enter cells and how to overcome intracellular barriers to reach the nucleus.

Mudhakir, Diky / Harashima, Hideyoshi

The AAPS journal

2009 Volume 11, Issue 1, Page(s) 65–77

Abstract: Viruses deliver their genome into host cells where they subsequently replicate and multiply. A variety of relevant strategies have evolved by which viruses gain intracellular access and utilize cellular machinery for the synthesis of their genome. ... ...

Abstract	Viruses deliver their genome into host cells where they subsequently replicate and multiply. A variety of relevant strategies have evolved by which viruses gain intracellular access and utilize cellular machinery for the synthesis of their genome. Therefore, the viral journey provides insight into the cell's trafficking machinery and how it can be best exploited to improve nonviral gene delivery systems. This review summarizes viral internalization pathways and intracellular trafficking of viruses, with an emphasis on the endosomal escape processes of nonenveloped viruses. Intracellular events from viral entry through nuclear delivery of the viral complementary DNA are also discussed.
MeSH term(s)	Adenoviridae/physiology ; Animals ; Caveolae/physiology ; Cell Nucleus/metabolism ; Clathrin-Coated Vesicles/physiology ; DNA, Complementary/metabolism ; DNA, Viral/metabolism ; Endocytosis/physiology ; Genetic Therapy/methods ; Humans ; Intracellular Membranes ; Membrane Fusion/physiology ; Pore Forming Cytotoxic Proteins/physiology ; Receptors, Virus/physiology ; Simian virus 40/physiology ; Viral Fusion Proteins/physiology ; Virus Attachment ; Virus Internalization
Chemical Substances	DNA, Complementary ; DNA, Viral ; Pore Forming Cytotoxic Proteins ; Receptors, Virus ; Viral Fusion Proteins
Keywords	covid19
Language	English
Publishing date	2009-02-05
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Review
ISSN	1550-7416
ISSN (online)	1550-7416
DOI	10.1208/s12248-009-9080-9
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Improving mechanical properties of desloratadine via multicomponent crystal formation.

Ainurofiq, Ahmad / Mauludin, Rachmat / Mudhakir, Diky / Umeda, Daiki / Soewandhi, Sundani Nurono / Putra, Okky Dwichandra / Yonemochi, Etsuo

European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences

2018 Volume 111, Page(s) 65–72

Abstract: We report the first multicomponent crystal of desloratadine, an important anti-histamine drug, with a pharmaceutically acceptable coformer of benzoic acid. The single crystal structure analysis revealed that this novel multicomponent crystal is ... ...

Abstract	We report the first multicomponent crystal of desloratadine, an important anti-histamine drug, with a pharmaceutically acceptable coformer of benzoic acid. The single crystal structure analysis revealed that this novel multicomponent crystal is categorized as salt due to the proton transfer from benzoic acid to the desloratadine molecule. By forming the salt multicomponent crystal, we demonstrated that the tabletability and plasticity of the multicomponent crystal was improved from the parent drug. In addition, neither capping nor lamination tendency was observed in the desloratadine-benzoic acid multicomponent crystal. The existence of a layered structure and slip planes are proposed to be associated with this improvement. The desloratadine-benzoate in this case shows an improved solubility in water and HCl 0.1N media and a better dissolution profile in water. However, the dissolution rate in HCl 0.1N media was found to be essentially indifference.
MeSH term(s)	Benzoic Acid/chemistry ; Crystallization ; Drug Compounding ; Elasticity ; Histamine H1 Antagonists, Non-Sedating/chemistry ; Hydrogen Bonding ; Loratadine/analogs & derivatives ; Loratadine/chemistry ; Models, Chemical ; Molecular Structure ; Solubility ; Tablets ; Tensile Strength
Chemical Substances	Histamine H1 Antagonists, Non-Sedating ; Tablets ; Loratadine (7AJO3BO7QN) ; Benzoic Acid (8SKN0B0MIM) ; desloratadine (FVF865388R)
Language	English
Publishing date	2018-01-01
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	1154366-8
ISSN	1879-0720 ; 0928-0987
ISSN (online)	1879-0720
ISSN	0928-0987
DOI	10.1016/j.ejps.2017.09.035
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Zs.A 3705: Show issues

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Article ; Online: A novel IRQ ligand-modified nano-carrier targeted to a unique pathway of caveolar endocytic pathway.

Mudhakir, Diky / Akita, Hidetaka / Tan, Erdal / Harashima, Hideyoshi

Journal of controlled release : official journal of the Controlled Release Society

2008 Volume 125, Issue 2, Page(s) 164–173

Abstract: In the present study, the cellular uptake and subsequent intracellular trafficking of liposomes was investigated, in which a novel peptide (IRQ), identified with in vivo phage display, was modified on the surface. Since the novel peptide IRQRRRR is rich ... ...

Abstract	In the present study, the cellular uptake and subsequent intracellular trafficking of liposomes was investigated, in which a novel peptide (IRQ), identified with in vivo phage display, was modified on the surface. Since the novel peptide IRQRRRR is rich in arginine, the cellular uptake mechanism was compared with octaarginine (R8)-modified liposomes, which are known to be taken up by cells via macropinocytosis. The uptake mechanism and intracellular trafficking of peptide-modified liposomes was determined by confocal laser scanning microscopy and flow cytometry analysis. Modification of the liposomal surface with the IRQ peptide (IRQ-Lip), induced internalization via a novel pathway-caveolar endocytosis-in parallel with clathrin-mediated endocytosis. Furthermore, the IRQ peptide stimulated escape from endocytic vesicles, leading to efficient gene silencing. When siRNA was condensed and encapsulated in an IRQ-modified multifunctional envelope-type nano-device (IRQ-MEND), transgene expression was reduced 52% with the fusogenic lipid, DOPE/CHEMS. This result shows that the novel IRQ can be utilized for cytoplasmic delivery of macromolecules. Moreover, the IRQ has the potential to be useful for delivery therapeutic agents to parenchymal cells via caveolar endocytosis, as this uptake pathway also plays an important role in transcytosis.
MeSH term(s)	Animals ; Caveolae/metabolism ; Clathrin/metabolism ; Endocytosis ; Gene Silencing ; Ligands ; Liposomes/administration & dosage ; Liposomes/metabolism ; Male ; Mice ; Mice, Inbred BALB C ; Muscle, Skeletal/metabolism ; NIH 3T3 Cells ; Nanostructures/administration & dosage ; Peptides/administration & dosage ; Peptides/metabolism ; RNA, Small Interfering/administration & dosage ; RNA, Small Interfering/metabolism ; Transfection
Chemical Substances	Clathrin ; Ligands ; Liposomes ; Peptides ; RNA, Small Interfering
Language	English
Publishing date	2008-01-22
Publishing country	Netherlands
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	632533-6
ISSN	1873-4995 ; 0168-3659
ISSN (online)	1873-4995
ISSN	0168-3659
DOI	10.1016/j.jconrel.2007.10.020
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Zs.A 2055: Show issues

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Article: Pharmacokinetic analysis of the tissue distribution of octaarginine modified liposomes in mice.

Mudhakir, Diky / Akita, Hidetaka / Khalil, Ikramy A / Futaki, Shiroh / Harashima, Hideyoshi

Drug metabolism and pharmacokinetics

2005 Volume 20, Issue 4, Page(s) 275–281

Abstract: We recently found that octaarginine modified liposomes (R8-Lip) can be efficiently internalized by cultured cells. The purpose of the present study was to quantitatively determine the effect of R8-density on the tissue distribution of R8-Lip in mice, ... ...

Abstract	We recently found that octaarginine modified liposomes (R8-Lip) can be efficiently internalized by cultured cells. The purpose of the present study was to quantitatively determine the effect of R8-density on the tissue distribution of R8-Lip in mice, using their clearance as an index. R8 was introduced in the form of stearylated R8 (STR-R8). The liposomes were composed of cholesterol and egg phosphatidylcholine and were labeled with [(3)H]cholesteryl hexadecyl ether. Various densities of R8 (3%, 10% and 30%) containing liposomes were prepared with a diameter of approximately 70-80 nm. The tissue distribution of R8-Lip was determined after their i.v. administration into mice and the effect of R8-density on tissue distribution was compared with uptake clearance, the calculated tissue distribution divided by the area under the blood concentration-time course. As results, R8-Lip were more rapidly eliminated from circulating blood and distributed to many tissues, especially liver depending on the R8-density. However, the tissue uptake clearance represented similar value to that of positively charge liposomes. Based on these results, we conclude that the R8-dependent increase in R8-Lip in various tissues tested indicates that positive charge, but not PTD function derived from R8 predominantly responsible for the enhancement of tissue distribution. Therefore, it is suggested that topology control of R8 is important to exhibit the PTD function.
MeSH term(s)	Animals ; Area Under Curve ; Liposomes/chemistry ; Liposomes/pharmacokinetics ; Liver/metabolism ; Male ; Mice ; Oligopeptides/chemistry ; Oligopeptides/pharmacokinetics ; Particle Size ; Protein Structure, Tertiary ; Tissue Distribution
Chemical Substances	Liposomes ; Oligopeptides ; octaarginine
Language	English
Publishing date	2005-09-01
Publishing country	England
Document type	Comparative Study ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2095748-8
ISSN	1347-4367 ; 0916-1139
ISSN	1347-4367 ; 0916-1139
DOI	10.2133/dmpk.20.275
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