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Srivastava, K., Shukla, A., Karthick, T., Velaga, S., Tandon, P., Sinha, K. & Shimpi, M. R. (2019). Molecular structure, spectroscopic signature and reactivity analyses of paracetamol hydrochloride monohydrate salt using density functional theory calculations. CrystEngComm, 21(5), 857-865
Open this publication in new window or tab >>Molecular structure, spectroscopic signature and reactivity analyses of paracetamol hydrochloride monohydrate salt using density functional theory calculations
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2019 (English)In: CrystEngComm, ISSN 1466-8033, E-ISSN 1466-8033, Vol. 21, no 5, p. 857-865Article in journal (Refereed) Published
Abstract [en]

The aim of this study was to understand the role of the intermolecular hydrogen bond interactions present in paracetamol hydrochloride monohydrated salt. Paracetamol hydrochloride monohydrate salt (PRA-HCl) and paracetamol (form I) were investigated via vibrational (FT-IR and FT-Raman) spectroscopy and density functional theory (DFT) to gain insight into the hydrogen bond patterns present in these crystalline materials. Two different density functionals, wB97X-D and M062X, were used for the comparison of the results. The geometrical parameters of PRA-HCl and form I obtained using these functional were compared with the crystallographic data, which proved the existence of intra-molecular and intermolecular hydrogen bonds. The C10O2 group of form I forms an intramolecular hydrogen bond, while the O1–H18 group of PRA-HCl forms an intermolecular hydrogen bond with a chloride ion (Cl), resulting in the elongation of the bond length and shift to a lower wavenumber for the O1–H18 group. To examine the potency of hydrogen bonding, quantum theory of atoms in molecules (QTAIM) calculations were performed and the results suggested that O1–H18⋯Cl22 is a strong intermolecular hydrogen bond. The chemical reactivity parameters reveal that the PRA-HCl and PRA-OXA cocrystals are more reactive and softer (low HOMO–LUMO energy gap) in comparison to paracetamol (form I).

Place, publisher, year, edition, pages
Royal Society of Medicine Press, 2019
National Category
Physical Chemistry Other Health Sciences
Research subject
Chemistry of Interfaces; Health Science
Identifiers
urn:nbn:se:ltu:diva-72732 (URN)10.1039/C8CE01761A (DOI)000458828500009 ()
Note

Validerad;2019;Nivå 2;2019-01-31 (johcin)

Available from: 2019-01-30 Created: 2019-01-30 Last updated: 2019-03-11Bibliographically approved
Hyun, S.-M., Joon Lee, B., Abuzar, S. M., Lee, S., Joo, Y., Hong, S.-H., . . . Hwang, S.-J. (2019). Preparation, characterization, and evaluation of celecoxib eutectic mixtures with adipic acid/saccharin for improvement of wettability and dissolution rate. International Journal of Pharmaceutics, 554, 61-71
Open this publication in new window or tab >>Preparation, characterization, and evaluation of celecoxib eutectic mixtures with adipic acid/saccharin for improvement of wettability and dissolution rate
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2019 (English)In: International Journal of Pharmaceutics, ISSN 0378-5173, E-ISSN 1873-3476, Vol. 554, p. 61-71Article in journal (Refereed) Published
Abstract [en]

Celecoxib (CEL) is a selective cyclooxygenase-2 (COX-2) inhibitor therapeutically indicated for the treatment of rheumatoid arthritis, osteoarthritis, acute pain, and inflammation. However, its poor solubility and dissolution rate significantly hinders its broader application. In this study, eutectic mixtures, as binary pharmaceutical compositions of CEL with adipic acid (ADI) and saccharin (SAC), were identified through a phase diagram and Tammann’s triangle intended to improve the wettability and dissolution rate of poorly water-soluble CEL. The contact angles at 0s in the liquid-solid interface were approximately θs (theta) 79.7° ± 0.50° and 86.65° ± 0.45° for CEL-ADI and CEL-SAC, respectively, which were much lower than the value obtained for CEL (92.05° ± 0.75° θ). Moreover, a comparison of the disk intrinsic dissolution rate and powder dissolution properties demonstrated that eutectic mixtures significantly increased the dissolution rate compared with CEL and physical mixtures. A general relationship was elucidated and indicated that the dissolution rate was increased as the contact angle decreased (correlation coefficient, r = 0.9966 ± 0.0031). Therefore, CEL-ADI and CEL-SAC eutectics may offer a novel formulation strategy to enhance the solubility and oral bioavailability of CEL.

Place, publisher, year, edition, pages
Elsevier, 2019
Keywords
Celecoxib, Eutectic, Evaporation crystallization, Phase diagram, Tammann’s Triangle, Contact angle
National Category
Other Health Sciences
Research subject
Health Science
Identifiers
urn:nbn:se:ltu:diva-71463 (URN)10.1016/j.ijpharm.2018.10.044 (DOI)000454421400007 ()30347274 (PubMedID)2-s2.0-85056228823 (Scopus ID)
Note

Validerad;2018;Nivå 2;2018-11-15 (johcin)

Available from: 2018-11-06 Created: 2018-11-06 Last updated: 2019-03-27Bibliographically approved
Velaga, S. (Ed.). (2018). Conference proceedings of the 4th Masterclass Psychiatry: Transcultural Psychiatry–Diagnostics and Treatment, Luleå, Sweden, 22–23 February 2018 (Region Norrbotten in collaboration with the Maudsley Hospital and Tavistock Clinic London). Paper presented at The 4th Masterclass Psychiatry: Transcultural Psychiatry–Diagnostics and Treatment, Luleå, Sweden, 22–23 February 2018 (Region Norrbotten in collaboration with the Maudsley Hospital and Tavistock Clinic London).
Open this publication in new window or tab >>Conference proceedings of the 4th Masterclass Psychiatry: Transcultural Psychiatry–Diagnostics and Treatment, Luleå, Sweden, 22–23 February 2018 (Region Norrbotten in collaboration with the Maudsley Hospital and Tavistock Clinic London)
2018 (English)Conference proceedings (editor) (Refereed)
Identifiers
urn:nbn:se:ltu:diva-72856 (URN)
Conference
The 4th Masterclass Psychiatry: Transcultural Psychiatry–Diagnostics and Treatment, Luleå, Sweden, 22–23 February 2018 (Region Norrbotten in collaboration with the Maudsley Hospital and Tavistock Clinic London)
Available from: 2019-02-12 Created: 2019-02-12 Last updated: 2019-02-12
Velaga, S., Djuris, J., Cvijic, S., Rozou, S., Russo, P., Colombo, G. & Rossi, A. (2018). Dry powder inhalers: An overview of the in vitro dissolution methodologies and their correlation with the biopharmaceutical aspects of the drug products. European Journal of Pharmaceutical Sciences, 113, 18-28
Open this publication in new window or tab >>Dry powder inhalers: An overview of the in vitro dissolution methodologies and their correlation with the biopharmaceutical aspects of the drug products
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2018 (English)In: European Journal of Pharmaceutical Sciences, ISSN 0928-0987, E-ISSN 1879-0720, Vol. 113, p. 18-28Article in journal (Refereed) Published
Abstract [en]

In vitro dissolution testing is routinely used in the development of pharmaceutical products. Whilst the dissolution testing methods are well established and standardized for oral dosage forms, i.e. tablets and capsules, there are no pharmacopoeia methods or regulatory requirements for testing the dissolution of orally inhaled powders. Despite this, a wide variety of dissolution testing methods for orally inhaled powders has been developed and their bio-relevance has been evaluated.

The review provides an overview of the in vitro dissolution methodologies for dry inhalation products, with particular emphasis on dry powder inhaler, where the dissolution behavior of the respirable particles can have a role on duration and absorption of the drug. Dissolution mechanisms of respirable particles as well as kinetic models have been presented. A more recent bio-relevant dissolution set-ups and media for studying inhalation biopharmaceutics were also reviewed. In addition, factors affecting interplay between dissolution and absorption of deposited particles in the context of biopharmaceutical considerations of inhalation products were examined.

Place, publisher, year, edition, pages
Elsevier, 2018
National Category
Other Health Sciences
Research subject
Health Science
Identifiers
urn:nbn:se:ltu:diva-65497 (URN)10.1016/j.ejps.2017.09.002 (DOI)000424975800003 ()28887232 (PubMedID)2-s2.0-85029717101 (Scopus ID)
Note

Validerad;2018;Nivå 2;2018-02-09 (andbra)

Available from: 2017-09-05 Created: 2017-09-05 Last updated: 2018-03-02Bibliographically approved
Velaga, S., Nikjoo, D. & Rao Vuddanda, P. (2018). Experimental Studies and Modeling of the Drying Kinetics of Multicomponent Polymer Films. AAPS PharmSciTech, 19(1), 425-435
Open this publication in new window or tab >>Experimental Studies and Modeling of the Drying Kinetics of Multicomponent Polymer Films
2018 (English)In: AAPS PharmSciTech, ISSN 1530-9932, E-ISSN 1530-9932, Vol. 19, no 1, p. 425-435Article in journal (Refereed) Published
Abstract [en]

The process of drying thin polymer films is an important operation that influences the film structure and solid state, and the stability of the product. The purpose of this work was to study and model the drying kinetics of multicomponent films based on two polymers: hydroxypropyl methylcellulose (HPMC, amorphous) and polyvinyl alcohol (PVA, semicrystalline). The isothermal drying kinetics of the films at different temperatures (40, 60, and 80°C) were studied using thermo-gravimetric analysis (TGA) and convection oven methods. Solid-state characterization tools used in the study included polarization and hot-stage microscopy, scanning electron microscopy (SEM), and differential scanning calorimetry (DSC). The drying kinetics of HPMC and PVA films in the TGA apparatus and convection oven were comparable. The three-parameter (Wmax, τ, n) Hill equation successfully modeled the experimental drying kinetics. The time factor τ in the Hill equation nicely explained two drying phases in the films. Solid-state phase changes occurring in the films during dehydration had a bearing on the drying kinetics and mechanisms. TGA can be used as a simple tool to determine the end points in drying processes using ovens or tunnels. The three-parameter Hill equation explained the drying kinetics and diffusion mechanisms of the solvent through the polymer films for the first time. This study advances our understanding of film drying, in particular for pharmaceutically relevant thin films.

Place, publisher, year, edition, pages
Springer, 2018
National Category
Other Health Sciences Other Materials Engineering
Research subject
Health Science; Engineering Materials
Identifiers
urn:nbn:se:ltu:diva-65096 (URN)10.1208/s12249-017-0836-8 (DOI)000419174600040 ()28762212 (PubMedID)
Note

Validerad;2018;Nivå 2;2018-01-23 (andbra)

Available from: 2017-08-15 Created: 2017-08-15 Last updated: 2018-04-11Bibliographically approved
AlHayali, A., Selo, M. A., Ehrhardt, C. & Velaga, S. (2018). Investigation of supersaturation and in vitro permeation of the poorly water soluble drug ezetimibe. European Journal of Pharmaceutical Sciences, 117, 147-153
Open this publication in new window or tab >>Investigation of supersaturation and in vitro permeation of the poorly water soluble drug ezetimibe
2018 (English)In: European Journal of Pharmaceutical Sciences, ISSN 0928-0987, E-ISSN 1879-0720, Vol. 117, p. 147-153Article in journal (Refereed) Published
Abstract [en]

The interplay between supersaturation, precipitation and permeation characteristics of the poorly water-soluble drug ezetimibe (EZ) was investigated. Supersaturation and precipitation characteristics of EZ in the presence of Caco-2 cells were compared to those in a cell-free environment. The effect of the water-soluble polymer polyvinyl pyrrolidone (PVP-K30) on the supersaturation, precipitation and transport of EZ was also investigated and the amount of drug taken up by Caco-2 cells was quantified.

A one-compartment setup without Caco-2 cells (i.e. in the wells of cell-culture plates) was used to mimic a non-sink in vitro dissolution chamber. The two-compartment Caco-2 cell monolayer setup (with apical and basolateral compartments) was used to investigate how the absorption of EZ affects supersaturation. EZ in varying degrees of supersaturation (DS; 10, 20, 30 and 40) was introduced into the one-compartment setup or the apical chamber of the two-compartment setup. Samples were collected at specific times to determine supersaturation, precipitation and permeation. At the end of the study, Caco-2 cells were lysed and the intracellular amount of EZ was quantified.

In the one-compartment setup, a high DS was associated with rapid precipitation. Supersaturation was maintained for longer time periods and precipitation was lower in the presence of Caco-2 cells. There were no significant differences in the absorption rate of the drug, even at high concentrations on the apical side. Permeability coefficients for all supersaturated solutions (i.e. DS 10–40) were significantly (p < 0.05) different from those when EZ was present in crystalline form. Both concentrations of PVP-K30 (i.e. 0.05% and 0.1% w/v) improved solubility and supersaturation of EZ when added to the apical side, however, the increase in absorption at the higher concentration was not proportional. The amount of intracellular EZ increased with increasing DS in the apical side, until the saturation limit was reached in the cells (i.e. at DS 30 and higher).

This study demonstrated that precipitation of EZ could be overestimated when supersaturation was investigated without the implementation of an absorption compartment in vitro, both in the absence and in the presence of polymer.

Place, publisher, year, edition, pages
Elsevier, 2018
National Category
Other Health Sciences
Research subject
Health Science
Identifiers
urn:nbn:se:ltu:diva-67527 (URN)10.1016/j.ejps.2018.01.047 (DOI)000430368800018 ()29408604 (PubMedID)2-s2.0-85042182339 (Scopus ID)
Note

Validerad;2018;Nivå 2;2018-03-01 (andbra)

Available from: 2018-02-06 Created: 2018-02-06 Last updated: 2019-03-27Bibliographically approved
Vuddanda, P. R., Alomari, M., Dodoo, C. C., Trenfield, S. J., Velaga, S., Basit, A. W. & Gaisford, S. (2018). Personalisation of warfarin therapy using thermal ink-jet printing. European Journal of Pharmaceutical Sciences, 117, 80-87
Open this publication in new window or tab >>Personalisation of warfarin therapy using thermal ink-jet printing
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2018 (English)In: European Journal of Pharmaceutical Sciences, ISSN 0928-0987, E-ISSN 1879-0720, Vol. 117, p. 80-87Article in journal (Refereed) Published
Abstract [en]

Warfarin is a widely used anticoagulant that is critical in reducing patient morbidity and mortality associated with thromboembolic disorders. However, its narrow therapeutic index and large inter-individual variability can lead to complex dosage regimes. Formulating warfarin as an orodispersible film (ODF) using thermal ink-jet (TIJ) printing could enable personalisation of therapy to simplify administration. Commercial TIJ printers are currently unsuitable for printing the milligram dosages, typically required for warfarin therapy. As such, this study aimed to modify a commercial TIJ printing system to formulate personalised warfarin ODFs containing therapeutic dosages. A TIJ printer was modified successfully with the printer functionality intact; the substrate (paper) rolling mechanism of the printer was replaced by printing onto a stationary stage. Free film substrates were composed of hydroxypropyl methylcellulose (20%w/w) and glycerol (3%w/w). The resulting ODFs were characterised for morphology, disintegration, solid-state properties and drug content. Printed film stability was assessed at 40 °C/75% relative humidity for 30 days. Therapeutic warfarin doses (1.25 and 2.5 mg) were successfully printed onto the film substrates. Excellent linearity was observed between the theoretical and measured dose by changing the warfarin feed concentration (R2 = 0.9999) and length of the print objective, i.e. the Y-value, (R2 = 0.9998). Rapid disintegration of the ODFs was achieved. As such, this study successfully formulated personalised warfarin ODFs using a modified TIJ printer, widening the range of applications for TIJ printing to formulate narrow therapeutic index drugs.

Place, publisher, year, edition, pages
Elsevier, 2018
National Category
Other Health Sciences
Research subject
Health Science
Identifiers
urn:nbn:se:ltu:diva-67510 (URN)10.1016/j.ejps.2018.02.002 (DOI)000430368800011 ()29414676 (PubMedID)2-s2.0-85042016848 (Scopus ID)
Note

Validerad;2018;Nivå 2;2018-03-02 (svasva)

Available from: 2018-02-05 Created: 2018-02-05 Last updated: 2018-06-11Bibliographically approved
Fritz, H. F., Ortiz, A. C., Velaga, S. & Morales, J. O. (2018). Preparation of a novel lipid-core micelle using a low-energy emulsification method. Drug Delivery and Translational Research, 8(6), 1807-1814
Open this publication in new window or tab >>Preparation of a novel lipid-core micelle using a low-energy emulsification method
2018 (English)In: Drug Delivery and Translational Research, ISSN 2190-393X, Vol. 8, no 6, p. 1807-1814Article in journal (Refereed) Published
Abstract [en]

High-energy methods for the manufacturing of nanomedicines are widely used; however, interest in low-energy methods is increasing due to their simplicity, better control over the process, and energy-saving characteristics during upscaling. Here, we developed a novel lipid-core micelle (LCM) as a nanocarrier to encapsulate a poorly water-soluble drug, nifedipine (NFD), by hot-melt emulsification, a low-energy method. LCMs are self-assembling colloidal particles composed of a hydrophobic core and a hydrophilic shell. Hybrid materials, such as Gelucire 44/14, are thus excellent candidates for their preparation. We characterized the obtained nanocarriers for their colloidal properties, drug loading and encapsulation efficiency, liquid state, stability, and drug release. The low-energy method hot-melt emulsification was successfully adapted for the manufacturing of small and narrowly dispersed LCMs. The obtained LCMs had a small average size of ~ 11 nm and a narrow polydispersity index (PDI) of 0.228. These nanocarriers were able to increase the amount of NFD dispersible in water more than 700-fold. Due to their sustained drug release profile and the PEGylation of Gelucire 44/14, these nanocarriers represent an excellent starting point for the development of drug delivery systems designed for long circulation times and passive targeting.

Place, publisher, year, edition, pages
Springer, 2018
Keywords
Lipid-core micelles; Low-energy method; Poorly water soluble drugs; Hot-melt emulsification; Nanocarriers
National Category
Other Health Sciences
Research subject
Health Science
Identifiers
urn:nbn:se:ltu:diva-68401 (URN)10.1007/s13346-018-0521-9 (DOI)000449290900019 ()29663150 (PubMedID)2-s2.0-85056114607 (Scopus ID)
Note

Validerad;2018;Nivå 2;2018-11-29 (inah)

Available from: 2018-04-18 Created: 2018-04-18 Last updated: 2018-12-03Bibliographically approved
Alomari, M., Vuddanda, P. R., Trenfield, S. J., Dodoo, C. C., Velaga, S., Basit, A. W. & Gaisford, S. (2018). Printing of T3 and T4 Oral Drug Combinations as a Novel Strategy for Hypothyroidism. International Journal of Pharmaceutics, 549(1-2), 363-369
Open this publication in new window or tab >>Printing of T3 and T4 Oral Drug Combinations as a Novel Strategy for Hypothyroidism
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2018 (English)In: International Journal of Pharmaceutics, ISSN 0378-5173, E-ISSN 1873-3476, Vol. 549, no 1-2, p. 363-369Article in journal (Refereed) Published
Abstract [en]

Hypothyroidism is a chronic and debilitating disease that is estimated to affect 3% of the general population. Clinical experience has highlighted the synergistic value of combining triiodothyronine (T3) and thyroxine (T4) for persistent or recurrent symptoms. However, thus far a platform that enables the simultaneous and independent dosing of more than one drug for oral administration has not been developed. Thermal inkjet (TIJ) printing is a potential solution to enable the dual deposition of T3 and T4 onto orodispersible films (ODFs) for therapy personalisation. In this study, a two-cartridge TIJ printer was modified such that it could print separate solutions of T3 and T4. Dose adjustments were achieved by printing solutions adjacent to each other, enabling therapeutic T3 (15–50 μg) and T4 dosages (60–180 μg) to be successfully printed. Excellent linearity was observed between the theoretical and measured dose for both T3 and T4 (R2 = 0.982 and 0.985, respectively) by changing the length of the print objective (Y-value). Rapid disintegration of the ODFs was achieved (< 45 seconds). As such, this study for the first time demonstrates the ability to produce personalised dose combinations by TIJ printing T3 and T4 onto the same substrate for oral administration.

Place, publisher, year, edition, pages
Elsevier, 2018
National Category
Other Health Sciences
Research subject
Health Science
Identifiers
urn:nbn:se:ltu:diva-70202 (URN)10.1016/j.ijpharm.2018.07.062 (DOI)000443255300035 ()30063938 (PubMedID)2-s2.0-85051384032 (Scopus ID)
Note

Validerad;2018;Nivå 2;2018-08-16 (andbra)

Available from: 2018-08-06 Created: 2018-08-06 Last updated: 2018-09-25Bibliographically approved
Taylor, D. M., Velaga, S. & Werneke, U. (2018). Reducing the stigma of long acting injectable antipsychotics: current concepts and future developments. Paper presented at 4th Masterclass Psychiatry: Transcultural Psychiatry - Diagnostics and Treatment, Luleå, Sweden, 22-23 February 2018 (Region Norrbotten in collaboration with the Maudsley Hospital and Tavistock Clinic London).. Nordic Journal of Psychiatry, 72(S1), S36-S39
Open this publication in new window or tab >>Reducing the stigma of long acting injectable antipsychotics: current concepts and future developments
2018 (English)In: Nordic Journal of Psychiatry, ISSN 0803-9488, E-ISSN 1502-4725, Vol. 72, no S1, p. S36-S39Article in journal (Refereed) Published
Abstract [en]

Background: Long acting injectable antipsychotics (LAI-APs) are considered a major advance in psychiatric treatment concerning treatment adherence and outcomes. Yet, both, doctors and patients remain sceptical. Aim: To explain the rationale for using LAI-APs, review their effectiveness and explore barriers to use. Method: Clinical overview of LAI-APs from the patient and doctor’s perspective. Results: LAI-APs were developed to increase adherence to treatment, thereby improving treatment outcomes. LAI-APs may reduce the risk of relapse and hospitalisation. Yet, the evidence from the few meta-analyses available remains weak. Both patients and doctors may associate LAI-APs with stigma and coercion. Current means of improving adherence include more focus on the therapeutic relationship, better information, adverse effects minimisation and half-life extension of LAI-APs. Future means of improving adherence include novel administration techniques that abolish the need for injection. Conclusions: For both, clinicians and drug developers, drug adherence remains a major target for improving treatment outcomes. 

Place, publisher, year, edition, pages
Taylor & Francis, 2018
Keywords
Antipsychotics, long-acting injections, adherence, relapse, blood-brain-barrier
National Category
Other Health Sciences
Research subject
Health Science
Identifiers
urn:nbn:se:ltu:diva-72803 (URN)10.1080/08039488.2018.1525638 (DOI)30688170 (PubMedID)2-s2.0-85060593033 (Scopus ID)
Conference
4th Masterclass Psychiatry: Transcultural Psychiatry - Diagnostics and Treatment, Luleå, Sweden, 22-23 February 2018 (Region Norrbotten in collaboration with the Maudsley Hospital and Tavistock Clinic London).
Note

Konferensartikel i tidskrift

Available from: 2019-02-12 Created: 2019-02-12 Last updated: 2019-04-23Bibliographically approved
Organisations
Identifiers
ORCID iD: ORCID iD iconorcid.org/0000-0002-0654-5410

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