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  1. AU="Kanagale, Pritam"
  2. AU=Wang Yupei
  3. AU="Egan, Kathleen M"
  4. AU="Prevezanou, Maria"
  5. AU="Márk, Lili"
  6. AU="Pellman, David S"
  7. AU="Wulf, Sarah"
  8. AU="DeVito, Michael"
  9. AU="Fehérvári, Lajos"
  10. AU="Sompa, Sagarika Adhikary"
  11. AU="Ladkany, Rand"
  12. AU=Jain Gaurav
  13. AU="Maldonado, Alejandra"
  14. AU="Junichi Takagi"
  15. AU="Aitor Rodriguez-Casanova"
  16. AU="Wimpenny, Claire"
  17. AU=Gao W J
  18. AU="Suarez-Almazor, Maria E"
  19. AU="Barciszewski, Jakub"
  20. AU=Madhusoodanan Jyoti
  21. AU="Korbecki, Jan"

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  1. Artikel ; Online: Development of a new age-appropriate, chewable tablet of mebendazole 500 mg for preventive chemotherapy of soil-transmitted helminth infections in pre-school and school-age children.

    Van Hove, Ben / Kanagale, Pritam / Quinten, Thomas / Gaiki, Sheetal / Collignon, Karin / Swar, Yogesh / Shah, Jimit / Verheyen, Ellen / Preda, Florentina-Maria / Samanta, Asim / Fernandez, Ernesto / Caporicci, Giuseppe / Ferreira, Teresa / Lequieu, Wouter / Masschelein, Johan / Schaufelberger, Daniel

    European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V

    2023  Band 188, Seite(n) 217–226

    Abstract: The aim of this study was to develop an age-appropriate tablet of mebendazole 500 mg to be used in large donation programs by the World Health Organization (WHO) for preventive chemotherapy of soil-transmitted helminth (STH) infections in pre-school and ... ...

    Abstract The aim of this study was to develop an age-appropriate tablet of mebendazole 500 mg to be used in large donation programs by the World Health Organization (WHO) for preventive chemotherapy of soil-transmitted helminth (STH) infections in pre-school and school-age children living in tropical and subtropical endemic areas. To that end, a new oral tablet formulation was developed that can be either chewed or given to young (≥1 year old) children by spoon after rapid disintegration to a soft mass with the addition of a small amount of water directly on the spoon. Although the tablet was manufactured using conventional fluid bed granulation, screening, blending, and compression processes, one of the main challenges was to combine properties of a chewable, dispersible, and regular (solid) immediate release tablet to meet the predefined requirements. The tablet disintegration time was below 120 s, allowing for administration by the "spoon method". The tablet hardness was higher (160-220 N) than normally applicable for chewable tablets, permitting shipment along a lengthy supply chain in a primary 200-tablet count bottle packaging. In addition, the resulting tablets are stable for 48 months in all climatic zones (I-IV). In this article, several aspects of the development of this unique tablet are described, including formulation, process development, stability, clinical acceptability testing, and regulatory filing.
    Mesh-Begriff(e) Animals ; Child ; Child, Preschool ; Humans ; Helminthiasis/drug therapy ; Helminthiasis/prevention & control ; Helminthiasis/epidemiology ; Helminths ; Mebendazole ; Soil ; Tablets
    Chemische Substanzen Mebendazole (81G6I5V05I) ; Soil ; Tablets
    Sprache Englisch
    Erscheinungsdatum 2023-05-18
    Erscheinungsland Netherlands
    Dokumenttyp Journal Article
    ZDB-ID 1065368-5
    ISSN 1873-3441 ; 0939-6411
    ISSN (online) 1873-3441
    ISSN 0939-6411
    DOI 10.1016/j.ejpb.2023.05.013
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  2. Artikel: Pharmaceutical development of solid dispersion based osmotic drug delivery system for nifedipine.

    Kanagale, Pritam / Patel, Vineetkumar / Venkatesan, Natarajan / Jain, Mukul / Patel, Pankaj / Misra, Ambikanandan

    Current drug delivery

    2008  Band 5, Heft 4, Seite(n) 306–311

    Abstract: Elementary osmotic pumps (EOP) are well known for delivering moderately soluble drugs at a zero order rate. A push-pull osmotic system was developed and commercialized for poorly water-soluble drugs [Procardia XL (Nifedipine), Glucotrl XL (Glipizide)]. ... ...

    Abstract Elementary osmotic pumps (EOP) are well known for delivering moderately soluble drugs at a zero order rate. A push-pull osmotic system was developed and commercialized for poorly water-soluble drugs [Procardia XL (Nifedipine), Glucotrl XL (Glipizide)]. However, the technology is complex comprising of bilayer compression and the suspension of drug formed in the core has more viscosity and has to withstand the osmotic pressure within the tablet, for which the membrane must be thicker than that of EOP. The aim of the present study was to develop a solid dispersion based EOP system for a poorly water-soluble drug, nifedipine and deliver it in a zero order fashion over an extended period of time. Solid dispersions were prepared by hot melt technique using Poloxamer-188 at various ratios of drug and polymer (1:1, 1:5 and 1:10, on weight basis) and investigated for solubility study. Formation of complex and decrease in crystallinity was confirmed from differential scanning calorimetry (DSC) and X-ray crystallography (XRD) study. Core tablets using solid dispersions were prepared and coated with cellulose acetate and PEG-400. An orifice was drilled manually to create passage for drug release. The system was optimized for amount of osmogent, membrane weight gain, amount of plasticiser and diameter of the orifice, to achieve desired release profile. The osmotic system was found to deliver nifedipine at a zero order rate for 20 h. The drug release from the developed formulation was independent of pH and agitational intensity.
    Mesh-Begriff(e) Chemistry, Pharmaceutical ; Drug Delivery Systems ; Hydrogen-Ion Concentration ; Nifedipine/administration & dosage ; Nifedipine/chemistry ; Osmosis ; Plasticizers/chemistry ; Poloxamer/administration & dosage ; Poloxamer/chemistry ; Solubility ; X-Ray Diffraction
    Chemische Substanzen Plasticizers ; Poloxamer (106392-12-5) ; Nifedipine (I9ZF7L6G2L)
    Sprache Englisch
    Erscheinungsdatum 2008-10-01
    Erscheinungsland United Arab Emirates
    Dokumenttyp Journal Article
    ZDB-ID 2185284-4
    ISSN 1875-5704 ; 1567-2018
    ISSN (online) 1875-5704
    ISSN 1567-2018
    DOI 10.2174/156720108785914998
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  3. Artikel ; Online: Formulation and optimization of porous osmotic pump-based controlled release system of oxybutynin.

    Kanagale, Pritam / Lohray, Braj Bhushan / Misra, Ambikanandan / Davadra, Prakash / Kini, Rajesh

    AAPS PharmSciTech

    2007  Band 8, Heft 3, Seite(n) E53

    Abstract: The aim of the current study was to design a porous osmotic pump-based drug delivery system for controlled release of oxybutynin. The porous osmotic pump contains pore-forming water-soluble additives in the coating membrane, which after coming in contact ...

    Abstract The aim of the current study was to design a porous osmotic pump-based drug delivery system for controlled release of oxybutynin. The porous osmotic pump contains pore-forming water-soluble additives in the coating membrane, which after coming in contact with water, dissolve, resulting in an in situ formation of a microporous structure. The dosage regimen of oxybutynin is one 5-mg tablet 2 to 3 times a day. The plasma half-life ranges from approximately 2 to 3 hours. Hence, oxybutynin was chosen as a model drug with an aim to develop a controlled release system for a period of 24 hours. Linear and reproducible release similar to that of Ditropan XL was achieved for optimized formulation (f2 >50) independent of hydrodynamic conditions. The effect of different formulation variables, namely, ratio of drug to osmogent, membrane weight gain, and level of pore former on the in vitro release was studied. Cellulose acetate (CA) was used as the semipermeable membrane. It was found that drug release rate increased with the amount of osmogent because of the increased water uptake, and hence increased driving force for drug release. Oxybutynin release was inversely proportional to the membrane weight gain; however, directly related to the level of pore former, sorbitol, in the membrane. This system was found to deliver oxybutynin at a zero-order rate for 20 hours. The effect of pH on drug release was also studied. The optimized formulations were subjected to stability studies as per International Conference on Harmonisation (ICH) guidelines and formulations were stable after a 3 month study.
    Mesh-Begriff(e) Chemistry, Pharmaceutical ; Delayed-Action Preparations ; Drug Stability ; Excipients ; Hydrogen-Ion Concentration ; Mandelic Acids/administration & dosage ; Mandelic Acids/chemistry ; Microscopy, Electron, Scanning ; Osmotic Pressure ; Porosity ; Solubility ; Tablets
    Chemische Substanzen Delayed-Action Preparations ; Excipients ; Mandelic Acids ; Tablets ; oxybutynin (K9P6MC7092)
    Sprache Englisch
    Erscheinungsdatum 2007-07-13
    Erscheinungsland United States
    Dokumenttyp Journal Article
    ZDB-ID 2052070-0
    ISSN 1530-9932 ; 1530-9932
    ISSN (online) 1530-9932
    ISSN 1530-9932
    DOI 10.1208/pt0803053
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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