Malgorzata Sznitowska

Medical University of Gdansk, Danzig, Pomeranian Voivodeship, Poland

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Publications (48)123.22 Total impact

  • Magdalena Czajkowska · Malgorzata Sznitowska · Peter Kleinebudde
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    ABSTRACT: The study was focused on the feasibility of measuring film thickness on minitablets and pellets by means of dynamic image analysis using Camsizer XT. Minitablets with diameters of 2.0mm or 2.5mm and pellets in the size range of 0.7-0.8mm with the polymer coating thickness of 80-170 micrometers were prepared and analyzed. In minitablets the film thickness was measured on the walls and edges and the difference was significant. The results were compared with the results obtained with the use of three microscopic methods (scanning and stereoscopic microscopy). Good correlation between dynamic image analysis and microscopic techniques was shown in the case of the film thickness in pellets and 2.0mm minitablets, but the measurement of the coating layer of larger particles (minitablets 2.5mm) was not sufficiently precise due to the non-isometric shape of these objects and the limited measuring range of the apparatus. Short analysis time, no need for sample preparation and a large number of objects under examination are main advantages of the proposed film thickness measurement by use of a dynamic image analysis. Copyright © 2015. Published by Elsevier B.V.
    No preview · Article · Sep 2015 · International Journal of Pharmaceutics
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    ABSTRACT: Minitablets are a novel, multi-compartment solid drug formulation, particularly intended for children between 1 to 6 years of age. Available literature shows that even infants are capable of swallowing a single minitablet. In this study, we have explored the level of acceptance of minitablets administered in units of 5 or 10. A group of thirty two 2-year-old children (2-yrs) and twenty eight 3-year-old children (3-yrs) have been enrolled in the study. Each child was asked to swallow placebo minitablets (2mm or 3mm) suspended in a fruity jelly on a spoon. The swallowing of minitablets (with or without chewing) was registered for 75% of 2-year-olds and for 93% of 3-year-olds. Moreover, most of the children (57% of all participants) were fully capable of swallowing all units without chewing (2-yrs: 50%; 3-yrs: 64%). However, no statistically significant differences in the swallowing ability were observed in gender and age groups. None of the children choked. Neither the number, nor the diameter of the administered minitablets have significantly influenced the ability to swallow units. The results show that minitablets administered in several units mixed with jelly food are safe and could be accepted by a paediatric population. Copyright © 2015. Published by Elsevier B.V.
    Full-text · Article · Feb 2015 · International Journal of Pharmaceutics
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    Monika Musko · Malgorzata Sznitowska
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    ABSTRACT: Abstract Available tablets or capsules for adults are often used to prepare extemporaneously formulated medicines appropriate for children. The most acceptable drug forms in pediatric population are oral liquids and pharmacists use commercial dispersing media to compound syrups from an active substance or from tablets available on the market. In many countries ready-to-use dispersing media are not available or refunded, but pharmacists can use other compounded media, providing their compatibility and stability are proven. The aim of this study was to formulate and evaluate the stability of syrups with candesartan cilexetil (1 mg mL-1) and valsartan (4 mg mL-1) extemporaneously prepared using commercial tablets (Diovan® and Atacand®). The following three different suspending media, which could be easily made in a pharmacy, were investigated: V1 - with xanthan gum (0.5 %), V2 - the USP/NF vehicle for oral solution and V3 - the medium based on a simple sucrose syrup. The stability of preparations was studied during 35 days of storage in a dark place at controlled temperature of 25 and 4 °C. During the study, microscopic observation was carried out and pH, viscosity, and concentration of candesartan cilexetil and valsartan were analyzed. Syrups with valsartan prepared with V2 and V3 media were stable for 3 or 4 weeks when stored at 25 °C, while syrups with candesartan were stable for as long as 35 days. For syrups prepared using V1 medium, the 14-day expiry date was not achieved because of microbial deterioration.
    Preview · Article · Dec 2014 · Acta Pharmaceutica
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    ABSTRACT: Pediatric parenteral nutrition enables normal growth even of preterm infants. Those children require, however, tailored parenteral nutrition and the creation of such can be challenging due to the risk of instability and shortages.
    Full-text · Article · Sep 2014 · Clinical Nutrition
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    Anna Kluk · Malgorzata Sznitowska
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    ABSTRACT: Modern solid multiparticulate drug forms (minitablets, pellets, granules) can provide the possibility of precise dosing or modified drug release or taste masking for medicines used in children. However, these solid particles require an adequate medium to ease swallowing. The aim of the research was to design a universal semisolid dispersing medium for administration of minitablets and pellets. High viscosity sodium carmellose and carbomer were considered as gelling agents. The hydrogels were prepared with sucrose, glycerol, and potassium sorbate or parabens. Preliminary studies were undertaken to estimate the application properties of the gels under conditions where a medicine is administered to a child. Besides standard tests (viscosity, sedimentation) the following measurements were conducted: gel ductility, mass of the gel removed from a spoon under shaking, ability of the gels to disperse solid particles, and disintegration of minitablets in the gels. The oral hydrogels prepared either with 1.0% and 1.5% carmellose or 0.25% and 0.5% (w/w) carbomer were suitable for dispersing and delivery of minitablets or pellets. Not only viscosity but also a ductility was an essential criterion in selecting the best vehicle. The in vivo perceptibility test for pellets and minitablets did not confirm that gels are more advantageous than syrups.
    Full-text · Article · Nov 2013 · International Journal of Pharmaceutics
  • Katarzyna Centkowska · Malgorzata Sznitowska
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    ABSTRACT: The aim was to evaluate ointments for local treatment of anal fissures. Nitroglycerin (NTG) was complexed with β-cyclodextrin (β-CD) to provide prolonged NTG release, with the intention of decreasing systemic drug absorption and thus reducing side effects. Gels, creams and anhydrous water-emulsifying (AWE) ointment with NTG-CD were compared with preparations containing uncomplexed NTG (diluted with crospovidone, NTG-cP). The in-vitro NTG release and ex-vivo skin absorption were studied. The prolonged-release ointment with the NTG-CD complex was formulated using AWE base or w/o cream (20% water); release of NTG from a hydrogel was very fast with both the complexed and uncomplexed forms. From the AWE ointment base, 16.4% or 4.5% of the total NTG dose was released after 6 h when NTG-cP or NTG-CD was incorporated, respectively. With the complexed form, NTG absorption to the skin after a 5-h application was 18.1 or 11.1 μg/g from AWE ointment or cream, respectively; absorption of the uncomplexed NTG was higher: 52.3 or 21.9 μg/g from AWE ointment and cream, respectively. Complexation with β-CD results in prolonged release of NTG from AWE ointment and w/o cream, which was confirmed by the ex-vivo skin absorption results.
    No preview · Article · Oct 2013
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    ABSTRACT: The aim of the work was to quantify possible interactions between surfactants and preserva-tives, comparing surface properties, in model pharmaceutical formulations. Surface parame-ters of 2-component surfactant-preservative a-quous mixtures were determined with a Wil-helmy plate technique, for the so-called principal surfactants (polysorbate 80, egg lecithin, phos-phatidylcholine) and preservatives, which were methylparaben and benzalkonium chloride (BA-C). A generalized surface tension vs. surfactant concentration plot signatures, in the presence of preservative at a fixed amount, allowed: the cri-tical micellar concentration (cmc) shift, additive molecules partition from the surface to the bulk, mixed micelles formation concentration, and ad-ditive surface removal concentration to be de-termined in reference to surface activity of the added substance. Methylparaben is a compound of lower (in comparison to BAC) surface activity, lower partitioning coefficient possessing lower energy and concentration of its removal from the surface, that makes it play effectively an an-timicrobial protection role in the bulk of phar-maceutical products, as already shown by che-mical tests.
    Full-text · Article · Oct 2012 · Journal of Biophysical Chemistry
  • Pawel Stasiak · Marcin Placzek · Przemyslaw Lepek · Malgorzata Sznitowska
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    ABSTRACT: Texture analyzer equipped with mucoadhesive rig has been used for determination of mucoadhesiveness of solid and semisolid drug formulations: lyophilizates, compressed tablets, and gels. Two different mucosa surrogates: mucin solution on a cellulose support and gelatin discs have been employed. The results obtained for different polymers are inconsistent and depend not only on the experimental model but also on the drug formulation. Addition of an excipient (e.g., lactose) or a drug (tramadol HCl, telmisartan) to the lyophilized polymer matrix generally resulted in decrease of observed adhesive forces which depended more on the polymer used than on the composition of the preparation. Due to low predictability of the effect of pharmaceutical formulation (type and composition) on the mucoadhesiveness of the polymer it has been concluded that individually designed experiments have to be applied for each preparation.
    No preview · Article · Dec 2011 · Journal of Dispersion Science and Technology
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    Radosław Kraciuk · Malgorzata Sznitowska
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    ABSTRACT: The objective of this study was to investigate the properties of granules and tablets with carbamazepine which were prepared employing a fluidized hot-melt granulation (FHMG) technique. The FHMG process was carried out at 65°C. Macrogol 6000 (PEG 6000) was used as a binder at the content 10% (w/w) of the granulated mass. Granules containing up to 70% (w/w) of the drug and 20-90% (w/w) of a filler (lactose, mannitol, calcium hydrogen phosphate (Di-Cafos), pregelatinized starch, and microcrystalline cellulose (MCC)) were produced. When the drug content was 30% (w/w), the yield of the process was satisfying (>95%) and flowability of the granules was better than placebo granules or drug-loaded granules prepared by wet granulation. Type of a filler had strong impact on physical properties of granules, and size distribution of the particles was the most homogenous when lactose or Di-Cafos were used. The FHMG technique enabled preparation of granules with better compressability compared with the wet-granulated product or with non-granulated powders. Tablets with shorter disintegration time than 10 min were obtained with 2.0% crospovidone added as a disintegrant. In comparison to tablets prepared from the wet-granulated mass, employment of the FHMG method resulted in tablets with faster dissolution of carbamazepine (more than 80% of the drug released within 15 min). This was achieved with mannitol or lactose/MCC, as fillers.
    Preview · Article · Sep 2011 · AAPS PharmSciTech
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    Pawel Stasiak · Malgorzata Sznitowska · Carsten Ehrhardt · Maria Luczyk-Juzwa · Pawel Grieb
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    ABSTRACT: Polymer-drug conjugates have gained significant attention as pro-drugs releasing an active substance as a result of enzymatic hydrolysis in physiological environment. In this study, a conjugate of 3-hydroxybutyric acid oligomers with a carboxylic acid group-bearing model drug (ibuprofen) was evaluated in vivo as a potential pro-drug for parenteral administration. Two different formulations, an oily solution and an o/w emulsion were prepared and administered intramuscularly (IM) to rabbits in a dose corresponding to 40 mg of ibuprofen/kilogramme. The concentration of ibuprofen in blood plasma was analysed by HPLC, following solid–phase extraction and using indometacin as internal standard (detection limit, 0.05 μg/ml). No significant differences in the pharmacokinetic parameters (C max, T max, AUC) were observed between the two tested formulations of the 3-hydroxybutyric acid conjugate. In comparison to the non-conjugated drug in oily solution, the relative bioavailability of ibuprofen conjugates from oily solution, and o/w emulsion was reduced to 17% and 10%, respectively. The 3-hydroxybutyric acid formulations released the active substance over a significantly extended period of time with ibuprofen still being detectable 24 h post-injection, whereas the free compound was almost completely eliminated as early as 6 h after administration. The conjugates remained in a muscle tissue for a prolonged time and can hence be considered as sustained release systems for carboxylic acid derivatives.
    Full-text · Article · Nov 2010 · AAPS PharmSciTech
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    ABSTRACT: Amorphous paclitaxel dissolves rapidly (1 mg mL(-1)) in an isotonic aqueous dispersion of egg lecithin (5% w/w), a new biocompatible submicron drug carrier consisting of structured aggregates with average size 0.5 microm. The solution is physically stable for at least 24 h and can be administered as an intravenous infusion. After a 5 h infusion in rabbits (0.66 mg kg(-1) h(-1)), changes in blood morphology were comparable to those observed in rabbits that received the commercial product Taxol. No changes in the enzyme profiles (alanine/aspartate aminotransferase or alkaline phosphatase) were observed. However, during infusion of the new formulation plasma concentration of paclitaxel (292 +/- 182 ng mL(-1)) was lower than observed after Cremophor-containing Taxol (540 +/- 262 ng mL(-1)). This result may indicate that the tissue distribution is different for the two drug formulations. Daily intraperitoneal administrations (3 doses/day) in mice demonstrated that the new carrier solution was non-toxic and, relative to Taxol, the new formulation exhibited similar or less toxicity.
    No preview · Article · Nov 2009 · Journal of Microencapsulation
  • Pawel Stasiak · Carsten Ehrhardt · Maria Juzwa · Malgorzata Sznitowska
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    ABSTRACT: A conjugate of ibuprofen with 3-hydroxybutyric acid oligomers has been evaluated as a novel drug delivery model system. This paper focuses on the synthesis and the characterisation of the physicochemical properties of this conjugate, and on hydrolysis studies in aqueous buffers and simulated intestinal fluid. We also describe the development of an analytical method (HPLC) for hydrolysis studies of this compound. The conjugate had high stability in aqueous solutions of pH 6-8 and underwent slow enzymatic hydrolysis. This conjugate is not well suited for oral administration but might be considered a candidate for development of prodrug preparations for parenteral or topical sustained release.
    No preview · Article · Sep 2009 · Journal of Pharmacy and Pharmacology
  • Krzysztof Cal · Malgorzata Sznitowska · Stanislaw Janicki
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    ABSTRACT: Drug-in-adhesive matrix-type transdermal therapeutic systems for indomethacin (IND) were formulated and evaluated. Silicone and two types of polyacrylates were used as the bases of matrices. Terpinolene was used as a penetration enhancer. The physicochemical properties of matrices were determined. The bioavailability study of IND was performed in rats. The presence of IND in blood was demonstrated for each system. The calculated pharmacokinetics parameters for IND mainly depend on the solubility of IND in the adhesive layer. The positive influence of a penetration enhancer on IND bioavailability was observed only for one type of polyacrylate matrices.
    No preview · Article · Oct 2008 · Drug Development and Industrial Pharmacy
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    ABSTRACT: Antimicrobial efficacy of methyl and propylparaben combination as potential preservatives for submicron emulsions, and the effect of oil and lecithin concentration on the microbial growth were investigated. Parabens were ineffective in standard or doubled concentrations as per pharmacopoeial criteria. Poor growth inhibition and multiplication of reference strains point to protective and growth properties of submicron emulsions. No correlation was observed between oil/lecithin ratio and efficacy of parabens; partitioning of the latter into the oily phase and lipophilic domains could be the reason for such effect. Further studies are necessary to establish a stable and safe composition of such formulations.
    No preview · Article · May 2008 · Drug Development and Industrial Pharmacy
  • Malgorzata Sznitowska · Malgorzata Klunder · Marcin Placzek
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    ABSTRACT: The aim of this study was to find a biocompatible, lecithin-based carrier for paclitaxel (PTX) suitable for intravenous infusion and ensuring a soluble PTX concentration of 100 mg/100 ml or higher for at least 24 h. Aqueous dispersions of egg or soya lecithin (water-lecithin dispersions, WLD), mixed micellar (MM) solutions of egg lecithin and sodium deoxycholate, and formulations containing lecithin plus the co-surfactants and co-solvents poloxamer, polysorbate, Span, benzalkonium chloride, and macrogol were investigated. Amorphous PTX was prepared by lyophilization. PTX co-lyophilized with surfactants was also studied. Unlike crystalline PTX, the drug in an amorphous form is easily soluble in 1-5% (w/w) WLD or in MM. The highest solubility (up to 570 mg/100 ml) was achieved in 5% WLD. Dissolved PTX precipitated from all tested formulations over 24 h. Despite this, concentrations of dissolved PTX of 100 mg/100 ml or higher were observed after 24 h in 5% egg WLD, 1-5% soya WLD, and in 5% MM (lecithin : deoxycholate ratio 1 : 1 w/w). When four different batches of 5% egg WLD were prepared, containing PTX in clinically relevant concentration of 100 mg/100 ml, no precipitation of PTX was observed within 24 h and this formulation is the most promising candidate for further in vivo studies. Neither additional surfactants nor co-lyophilization increased PTX solubility in the lecithin-based carriers. The use of parenteral emulsions as solvents for the co-lyophilized PTX also failed to increase the solubility of the drug up to the target concentration.
    No preview · Article · Feb 2008 · CHEMICAL & PHARMACEUTICAL BULLETIN
  • Dorota Watrobska-Swietlikowska · Malgorzata Sznitowska
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    ABSTRACT: Partitioning of methyl and propyl parabens (methyl and propyl hydroxybenzoate, paraben M and P) between the major phases in the parenteral submicron emulsions was studied. The investigated emulsions contained 10% or 20% soya-bean oil, 1.2% or 2.4% egg lecithin, 0.18% or 0.36% paraben M and 0.02% or 0.04% paraben P. The aqueous phase was obtained by ultracentrifugation, and subsequently, it was subjected to ultrafiltration, which procedure allowed to distinguish between the fractions of free preservatives (Fw) and incorporated in the liposomal or micellar region (Flm). The fractions present in the oily phase and in the interface were calculated. Depending on the formulation, Fw was 17-31% and 2.3-6.0% for paraben M and P, respectively. The Flm values were in a very narrow range, i.e. 3.0-6.0% for both preservatives. Substantial accumulation, i.e. 38-58% was found in the interface and the partitioning into this region was related to the oil/lecithin ratio rather than to lipophilicity of the preservative.
    No preview · Article · May 2006 · International Journal of Pharmaceutics
  • Justyna Pietkiewicz · Malgorzata Sznitowska · Marcin Placzek
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    ABSTRACT: The aim of the study was to compare incorporation of bupivacaine base, bupivacaine stearate and indomethacin in diluted suspensions of lipospheres (10%, w/w of lipid) and in concentrates (50%, w/w of lipid). The lipid cores were composed of a mixture of solid and liquid triglycerides (Precirol and Miglyol 4:1). The lipospheres sizing between 0.5-10 microm (suspensions) and 0.5-20 microm (concentrates) were prepared using a hot emulsification with high-shear mixing and cold resolidification method. None of the studied drugs was successfully incorporated in the lipid core. The increased incorporation of drugs determined in the concentrated lipospheres was only apparent, since in fact all the dose was only attached to the surface of the lipid particles and was transferred to the aqueous phase in the course of an intensive agitation. The presence of hydrophilic polymers in the aqueous phase did not prevent the expulsion effect although drug precipitation was retarded. The expulsion effect did not correlate with the solubility of drugs determined in the bulk lipids.
    No preview · Article · Apr 2006 · International Journal of Pharmaceutics
  • Krzysztof Cal · Katarzyna Kupiec · Malgorzata Sznitowska
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    ABSTRACT: The terpenes disturb lipid arrangement in the intercellular region of the stratum corneum (SC) that leads to the increased permeability of the skin. This effect is used in technology of transdermal drug forms and depends on physicochemical properties of terpenes and their amounts penetrated to the stratum corneum; however terpenes do not need penetrate into viable skin tissue and this event is not even desired. To correlate skin absorption and elimination kinetics of four cyclic terpenes, namely alpha-pinene, beta-pinene, eucalyptol and terpinen-4-ol, applied as neat substance with their physicochemical properties. The terpenes were applied onto the human skin in vitro, and after 1-4 h their content in the separated by a tape-stripping method stratum corneum layers and in the epidermis/dermis was determined using GC. Similarly, the amounts of terpenes in the skin were analysed during 4 h following 1 h absorption. The fastest and progressive penetration into all skin layers was observed for terpinen-4-ol. All studied terpenes are absorbed in the viable epidermis/dermis, however penetration into this layers is time-dependent process, constantly increasing during 4 h. Like for stratum corneum, the largest cumulation in epidermis/dermis was observed for terpinen-4-ol. The elimination of terpenes from the stratum corneum was fast, especially in deeper layers, and much faster if the initial cumulation was small. Investigated cyclic terpenes represent different penetration and elimination characteristics and do not permeate across the skin to the acceptor medium due to large cumulation in the skin tissue. The penetration of terpenes into stratum corneum is greater if their log P-value is close to 3.
    No preview · Article · Mar 2006 · Journal of Dermatological Science
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    M Sznitowska · J Pietkiewicz · M Stokrocka · S Janicki
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    ABSTRACT: A dissolution test for oral veterinary pastes with ivermectin using the Ph. Eur. paddle apparatus was developed. Sink conditions were achieved with sodium lauryl sulphate in a concentration of 0.5% as dissolution medium. By means of HPLC fast degradation of ivermectin was observed in HCl 0.1 M solution. Rotation speed of the paddle at 75 rpm was appropriate as demonstrated in a study comparing two different products.
    Preview · Article · Nov 2004 · Pharmazie
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    J Pietkiewicz · M Sznitowska
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    ABSTRACT: Suspensions of lipid microspheres sizing from 1 to 30 microm, whose fluidity and lipid/surfactant composition is suitable for parenteral administration were developed. None of the formulations prepared with Precirol (palmitostearate), as the only lipid, was physically stable during storage, because liquid suspensions formed semisolid gels within one week. Stable 10% (w/w) suspensions of lipid microspheres were produced using saturated triglycerides in combination with medium chain unsaturated triglycerides (Miglyol) as lipids and polysorbate 80 (2% w/w) as a surfactant.
    Preview · Article · May 2004 · Pharmazie

Publication Stats

580 Citations
123.22 Total Impact Points


  • 1996-2015
    • Medical University of Gdansk
      • • Department of Pediatrics, Gastroenterology, Hepatology and Nutrition
      • • Department of Physical Chemistry
      • • Department of Forensic Medicine
      Danzig, Pomeranian Voivodeship, Poland
  • 1994-1995
    • University of California, San Francisco
      • Department of Dermatology
      San Francisco, California, United States