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Surface-active agents from the group of polyoxyethylated glycerol esters of fatty acids. Part IV. Equilibrium micellar solubilization of selected lipophilic therapeutic agents (BCS class II and III) in aqueous solutions of products of catalytic oxyethylation of triglyceride fractions extracted from pharmacopoeial lard (Adeps suillus PP XI) of nTE≥50

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Marczyński Z., Kołodziejczyk M. K., Nachajski M. J., Zgoda M. M.

Acta Poloniae Pharmaceutica - Drug Research

2019

vol. 76

issue 4

707-714

Summary: Preformulation studies were carried out to estimate the solubilization capacity of products of catalytic oxyethylation of triglyceride fractions extracted from the pharmacopoeial lard (Adeps suillus, PP XI). There were determined basic viscosity ([ɳ], Mɳ) and hydrodynamic (Ro, Robs., Ω) values of micellar solutions of oxyethylated derivatives as well as their surface activity - . Critical micellar concentration (cmc) was used to calculate the thermopotential for the formation of micelles (∆ ). Model studies on micellar solubilization of gemfibrozil, loratadine and valsartan from the solid body surface (phase boundary) were performed under equilibrium conditions at the surfactant concentration of cexp>>cmc. The amount of dissolved lipophilic therapeutic agents with qualitative and quantitative involvement of micellar solubilization was determined by spectrophotometric (UV) method - cǀsǀ (mg/100mL) as well as by calculating the solubilization indices - n|s| (mol / mol). The research study has identified structures of oxyethylated derivatives of triglyceride fractions which selectively and effectively solubilize gemfibrozil, loratadine and valsartan from the solid surface in the equilibrium system. The obtained results are a technological inspiration to create a model form of the drug (tablet) with continuous dispersion of lipophilic therapeutic agents (gemfibrozil, loratadine and valsartan), obtained on the basis of the liquefied surfactant structure. Key words: micellar solubilization, products of triglyceride fraction ethoxylation, gemfibrozil, loratadine, valsartan

DEVELOPMENT AND IN-VITRO CHARACTERIZATION OF NANOEMULSION-BASED BUCCAL PATCHES OF VALSARTAN

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Abu-Huwaij R. T., Hamed R., Daoud E., Alkilani A.

Acta Poloniae Pharmaceutica - Drug Research

2019

vol. 76

issue 2

313-321

The aim of the study was to develop and characterize mucoadhesive buccal patches of valsartan (VAL) in nanoemulsion (NE) form and to evaluate the impact of this formulation in improving its solubility, mucoadhesive strength and in-vitro permeation in comparison to the traditional mucoadhesive VAL patches. A thermodynamic stable VAL-loaded NE was constructed and evaluated by centrifugation, heating/cooling cycles, and freeze/thaw cycles. It had a mean droplet size of 22.5 nm and composed of 40% w/w water, 10% w/w oleic acid: Labrasol® at a ratio of 2:1 v/v, 50% w/w polysorbate 20: Transcutol®-P at a ratio of 1:3 v/v and. Bi-layered patches were prepared using 3% w/v ethylene vinyl acetate in dichloromethane as backing layer and 1.5% w/v Carbopol® 971P aqueous solution with VAL-loaded NE as mucoadhesive layer . Patches showed acceptable weight variation, thickness, drug loading, folding endurance, mucoadhesive strength and in-vitro permeation. NE-based patches were more effective in enhancing the penetration of VAL than traditional patches, without significant difference in the mucoadhesive strength. They showed higher steady state flux and permeability coefficient than the traditional patches with a flux enhancement ratio of 2.36. The study concluded that reducing the particle size to the nano-scale appears to be a promising approach to obtain VAL products with higher drug permeability that can be tailored to optimize drug release profile in-vivo.

Internet jako źródło informacji dla polskich pacjentów na temat leków wstrzymanych i wycofanych z obrotu na przykładzie produktów leczniczych zawierających walsartan – analiza z wykorzystaniem Google Trends

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Świeczkowski D., Zdanowski S., Merks P., Jaguszewski M.

Farmacja Polska

2019

vol. 75

issue 10

531-535

Background In addition to community pharmacies, the Internet has become an important source of information about medicines for patients, including medication recalls on the example of drugs containing valsartan. Aim The aim of the study was to verify a hypothesis that the frequency of specific Google searches in Polish increased during the periods of large scale valsartan recalls form the market which occurred between July 1st, 2018 and September 22nd 2019. Such increase would indicate that Google search engine is used by patients as a tool to seek information about withdrawn and recalled drugs. Material and methods Google Trends was used to obtain data on the relative frequency of searches of specific phrases connected to the topic. Four two-week periods, when valsartan formulations were being withdrawn from the Polish market, were identified and Poisson test was used to analyze the relative frequencies between those specified periods and the rest of the analysed timespan. All analyses were performed in R 3.5.3. P-values less than 0.05 were considered statistically significant. The results are reported with 95% CI. Results The relative frequency of searches including the phrase “walsartan wycofany” (eng. valsartran recalled) during the periods of the drug recalls was λ1 = 1,69 [1,56 - 1,83] while outside those periods it equalled λ2 = 0,52 [0,48 - 0,56]. For the second analysed phrase – “dyrektywa fałszywkowa” (ang. Falsified Medicine Directives) the values wereλ1 = 6,33 [6,07 - 6,58] and λ2 = 3,15 [3,06 - 3,25], respectively. In both cases the difference was statistically significant with p < 0,001. Conclusions During the periods of withdrawal and recall from the market of specific formulations containing valsartan and significant increase in the frequency of Google queries connected to the topic was registered. It may indicate that Google search engine, and more generally the Internet, is a significant source of information for Polish patients during periods in which medicinal products are being recalled. To fully appreciate the scope and the nature of the phenomenon, further quantitative and qualitative research is needed.

Przedmiot badań Obok aptek ogólnodostępnych Internet stał się istotnym źródłem informacji na temat leków dla pacjentów, również w obszarze wstrzymania i wycofywania produktów leczniczych z obrotu. Cel badań Celem badania było zweryfikowanie hipotezy badawczej, mówiącej o tym, że częstość wyszukiwania fraz związanych z wycofaniem produktów leczniczych zawierających walsartan („walsartan wycofany”, „dyrektywa fałszywkowa”) w okresie masowego wycofywania walsartanu jest większa niż w pozostałych okresach analizowanego przedziału czasowego, w konsekwencji wykazanie, że wyszukiwarka Google jest wykorzystywane przez pacjentów jako źródło informacji na temat wstrzymanych i wycofanych produktów leczniczych. Materiał i metody Dokonano analizy na podstawie danych uzyskanych z narzędzia Google Trends. Celem udzielenia odpowiedzi na postawione pytania badawcze przeprowadzono analizy statystyczne przy użyciu oprogramowania R 3.5.3. Przeprowadzono analizę z wykorzystaniem testu Poissona. Za próg istotności uznano α = 0,05. Wyniki W przypadku frazy „walsartan wycofany” zaobserwowano częstość wyszukiwania w okresie wycofywania walsartanu na poziomie λ1 = 1,69 [1,56 - 1,83], zaś w pozostałym okresie λ2 = 0,52 [0,48 - 0,56]. W przypadku frazy „dyrektywa fałszywkowa” zaobserwowano częstość wyszukiwania w okresie wycofywania walsartanu na poziomie λ1 = 6,33 [6,07 - 6,58], zaś w pozostałym okresie λ2 = 3,15 [3,06 - 3,25]. Różnica pomiędzy obiema wartościami okazała się istotna statystycznie: p < 0,001. Wnioski W okresach wycofywania i wstrzymania w obrocie produktów leczniczych zawierających walsartan zaobserwowano istotnie częstsze wyszukiwanie fraz „walsartan wycofany” oraz „dyrektywa fałszywkowa” w porównaniu do pozostałego okresu w analizowanym przedziale czasowym. Może to świadczyć o tym, że wyszukiwarka Google (Internet) jest źródłem informacji o wycofanych i wstrzymanych lekach dla pacjentów w Polsce.

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2 Acta Poloniae Pharmaceutica - Drug Research

1 Farmacja Polska

3 2019

1 Abu-Huwaij R. T.

1 Alkilani A.

1 Daoud E.

1 Hamed R.

1 Jaguszewski M.

1 Kołodziejczyk M. K.

1 Marczyński Z.

1 Merks P.

1 Nachajski M. J.

1 Zdanowski S.

1 Zgoda M. M.

1 Świeczkowski D.

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DEVELOPMENT AND IN-VITRO CHARACTERIZATION OF NANOEMULSION-BASED BUCCAL PATCHES OF VALSARTAN

Internet jako źródło informacji dla polskich pacjentów na temat leków wstrzymanych i wycofanych z obrotu na przykładzie produktów leczniczych zawierających walsartan – analiza z wykorzystaniem Google Trends