Piotr Paduszyński

- Colorcon Formulation School
- Colorcon Coating School
- Basf excipiens Customer Seminar
- Laboratorium Farmaceutyczne: Badania preformulacyjne w rozwoju formulacji tabletek
- Problemy technologiczne związane z wytwarzaniem tabletek i kapsułek
- Biohoryzonty 2012 - reprezentowanie Wydziału Biotechnologii Uniwersytetu Wrocławskiego na panelu dyskusyjnym
- Croda Emulsifier Academy
- Naukowiec w Biznesie
- Assign Clinical Research Sp. Z o.o. and Investin Sp. Z. o. o. Project management research
- QbD and DoE Seminar Statsoft
- Colorcon Formulation School and IMA Equipment Schowcase

Risk management using FMEA

Uniwersytet Wrocławski
Centrum Badawczo - Rozwojowe Novasome
Uniwersytet Medyczny im. Pisatów Śląskich w Wrocławiu
PPF Hasco - Lek

New effective azelaic acid liposomal gel formulation of enhanced pharmaceutical bioavailability

data publikacji 8 lip 2016 opis publikacji Biomedicine & Pharmacotherapy 83 (2016) 771–775

opis publikacji Azelaic acid is a naturally occurring saturated C9-dicarboxylic acid which has been shown to be effective in the treatment of comedonal acne and inflammatory acne, as well as hiperpigmentary skin disorders.
The aim of the present study is to compare new developed liposomal hydrogel (lipogel) and commercially available product in terms of the active substance—azelaic acid bioavailability. Topical formulations were evaluated for physical parameters, such as pH measurement, organoleptic evaluation and liposome size analysis in lipogel formulation. In addition, studies were performed on in vitro antimicrobial preservation, stability and accumulation in the stratum corneum according to guidelines established by European Pharmacopoeia and International Conferences on Harmonisation. The new formula for liposomal gel with azelaic acid has the stability required for pharmaceutical preparations. Moreover, presented formulation F2 reveals a very high accumulation (187.5 mg/cm2) of an active substance in the stratum corneum, which results in opportunity to decrease of the API content to 10% in comparison to a reference formula: commercially available cream with 20% of azelaic acid. The study reveals that the final formula of lipogel F2 with azelaic acid had acceptable physical parameters that showed that they were compatible with the skin and in addition this formulation passed stability studies. In vitro antimicrobial preservation studies showed that the formulated lipogel F2 showed strong antibacterial activity; thus, no preservatives were added to the final composition of the preparation. The present study concludes that
the formulated lipogel F2 with azelaic acid is stable, efficient in antimicrobial preservation and reveals improved active substance bioavailability.

Early Stage of Drug Release Non-Classified in BCS Influenced By Coating Excipients: Hydroxypropyl Methylcellulose and Polyvinyl Alcohol

data publikacji 1 sty 2016 opis publikacji Lat. Am. J. Pharm. 35 (1): 84-90 (2016)

opis publikacji SUMMARY. The aim of the study was to evaluate the influence of polymer coatings with hydroxypropyl methylcellulose (HPMC) and polyvinyl alcohol (PVA), on the course of the release kinetics of the active pharmaceutical ingredient (API) non-classified in BCS, from coated tablets. The tablets were prepared via granulation, and compression in rotary tablet press, using an aqueous solution of the binder in a mixer- granulator using amphiphilic API, HPMC, microcrystalline cellulose (MCC), sodium starch glycolate type A, lactose monohydrate, magnesium stearate. The coating mixtures used for dispersion were prepared of two commercially available preparations, containing respectively, in the first case PVA and talc, and in the second case HPMC and MCC. Designated constant release rates of the API ranged from 1.47 to 2.01 × 10–1min –1 , respectively, for tablets coated with material based on PVA with talc, and for tablets coated with HPMC and MCC. Surprising release rates were observed for the tablets coated with material based on HPMC and MCC. The coated tablets were characterized by almost the same, and even slightly higher
average release rate compared to the uncoated tablets, designated within the first 9 min of measurement. The use of HPMC in the mixture with MCC, as a coating agent, reduces the amount and the rate of release of API in the acidic buffers and at pH near to neutral. However with increasing pH of the buffer the amount of released API increases. A mixture of PVA with talc, used as a film coating allows the formation of the coat less sensitive to the pH of the acceptor fluid, used in the study of the kinetics of release.

Influence of pH Conditions and the Type of Measurement Device on the Release Rate of Clozapine from Commercially Available 100 mg Tablets

data publikacji 5 maj 2014 opis publikacji Lat. Am. J. Pharm. 33 (3): 447-52 (2014)

opis publikacji SUMMARY
. The aim of this study was to determine the effect of various acceptor fluids on the release ki-
netics of clozapine from the tablets containing 100 mg of the drug, and to assess the impact of research method on the release kinetics of clozapine to the acceptor fluid at the critical pH, below the “sink” condi- tions. The dissolution studies were performed using 0,1 M HCl, acetate buffer of pH 4,5, and phosphate buffer R1 of pH 6,8. The last one buffer was applied both in the classical paddle apparatus, and in the flow-through cell. The release rates in the first stage were in the range between 2,26×10–1 min –1 and 8,60×10-3 min –1 , whereas in the identified second stage the rates ranged the values of 2,40×10 –3 min –1 and 1,00×10-3 min –1 . Due to the obtained data, with an increase of pH of the acceptor fluid, the release rates decrease respectively, according to proposed kinetic equation. The use of a buffer with a relatively high pH, i.e. phosphate buffer at pH 6.8, enables extended observation of changes of clozapine concentration in the donor compartment. The flow device gives the opportunity to exhaust the total dose of the drug, whereas in the paddle apparatus the solubility of the active substance limits its concentration in acceptor fluid.

International patent: WO 2012/117385 A2 "Liposome formulation comprising an anti-tumor active substance, method for its preparation and pharmaceutical compositions comprising it."

paź 2010 – lut 2011

Opis projektu
http://www.sumobrain.com/patents/wipo/Liposome-formulation-comprising-anti-tumour/WO2012117385.html