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1

Hydrożele w recepturze aptecznej leków dermatologicznych

100%

Jacyna B., Maciejewski B., Sznitowska M.

Farmacja Polska

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2020

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vol. 76

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issue 1

57-62

EN

Hydrogels are a physicochemical system in which an aqueous phase is gelled with a certain gelling polymer. They can make a good alternative to conventional lipophilic or absorption ointment bases, especially if the medicine should be administered to mucosa, because the gelling polymers interact with a mucose what results in mucoadhesion. The use of a hydrogel is preferred to lipophilic ointments in severe inflammations, exudative wounds, acne, oily skin or when the application area on the skin is hairy. Hydrogels also provide a cooling sensation on the skin, when water evaporates and this process is endothermic. Hydrogels are relatively popular also in a compounding practice in other countries, such as USA, where various types of commercially-made hydrogel bases are available. Despite the fact that hydrogels are accepted by law as compounded dosage forms, in Poland they have not been prepared in pharmacies because neither such bases nor suitable polymers are formally registered excipients for drug compounding, and the registration procedure is similar to the one for drug products authorization. The article describes hydrogels as there are first such materials available for pharmacists who are involved in compounding practice. Three gel-forming polymers: methylcellulose, hypromellose and hydroxyethylcellulose and hydrogel bases dedicated for drug compounding are characterized. Several examples of preparations with various active substances are presented and methods of their preparations are proposed. A dermatological base, Celugel, composed of hydroxyethylcellulose and recently registered in Poland for pharmacy compounding is also presented. Special attention is given to methods of hydrogel preparation, depending on the solubility profile of a certain type of polymer. Stability of the compounded hydrogels is discussed, especially regarding microbiological quality and the presence of preservatives. The benefits of these formulations are indicated including a relatively low cost of the hydrogel bases resulting from a low content of the polymers.

PL

Hydrożele dermatologiczne stanowią atrakcyjną alternatywę dla maści na podłożach lipofilowych oraz absorpcyjnych, szczególnie, gdy lek ma być podany na błony śluzowe. Łatwość sporządzenia hydrożelu oraz relatywnie niski koszt to dodatkowe zalety, jednak skomplikowany proces rejestracji polimerów żelujących jako substancji do receptury w Polsce skutkuje brakiem surowców do sporządzania nowoczesnych hydrożeli. Niniejszy artykuł ma na celu przybliżenie postaci hydrożelu w kontekście preparatyki recepturowej w sytuacji, gdy zaczęły być dostępne pierwsze takie surowce.

2

Trudności w sporządzaniu recepturowych kropli do oczu z cyklosporyną A

100%

Wolska E. K., Gajewska M., Sznitowska M.

Farmacja Polska

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2019

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vol. 75

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issue 11

623-632

EN

Cyclosporine A is very effective in treatment of many ophthalmic pathologies like immunological and inflammatory diseases of the cornea, conjunctive or uvea. It is also used to prevent corneal graft rejection and to treat dry eye syndrome. Local ocular administration significantly reduces the risk of systemic side effects. Currently on the market are two products in the form of eye drops: Restasis® (0.05% of cyclosporine) in US and Ikervis® (0.1% of cyclosporine) in the EU. Both are in the form of oil-in-water emulsion. Their availability is still limited and cyclosporine concentration is low. This is a reason that compounded formulations are prepared in hospital and retail pharmacies. The pharmacists do not have an access to the substance and use injectable (50 mg/ml cyclosporine), oral solutions (100 mg/ml cyclosporine) or even oral capsules (25-100 mg/capsule) as the source of cyclosporine. That allows to use of cyclosporine for topical ophthalmic applications in varies formulations, indications, concentration and posology. Due to the fact that cyclosporine is a highly lipophilic and poorly water soluble, it is mostly compounded and administered as an oily solution. Unfortunately, that dosage form is poorly tolerated after administration to the eye, mainly due to the fact of blurring vision commonly observed because of the high viscosity of the oils. However, for many patients use of compounded eye drops with cyclosporine can be the only hope to alleviate the symptoms of the disease, and sometimes even to avoid vision loss. When pharmaceutical compounding of eye drops with cyclosporine, the problem is the presence of auxiliary substances such as, for example, Cremophor, ethanol evaporation, or obtaining the exact dose of the active substance from capsules. This article gives an overview of different approaches for compounding of the cyclosporine eye drops in hospital and retail pharmacies using marketed products off-label. Benefits and the limitations of each method are presented with comments regarding the proper drug compounding.

PL

Cyklosporyna A jest skuteczna w leczeniu wielu chorób oczu, takich jak choroby immunologiczne i zapalne rogówki, spojówki czy naczyniówki. Jest również stosowana w zapobieganiu odrzucenia przeszczepu rogówki i leczeniu zespołu suchego oka. Preferowane jest miejscowe podanie cyklosporyny bezpośrednio do oka, by zmniejszyć ryzyko wystąpienia ogólnoustrojowych działań niepożądanych. Ze względu na ograniczoną dostępność gotowych kropli do oczu z cyklosporyną, zwłaszcza w wyższym stężeniu (0,5-2%), w aptekach szpitalnych i ogólnodostępnych sporządzane są recepturowe krople do oczu z wykorzystaniem roztworu do wstrzykiwań lub roztworu doustnego jako źródła cyklosporyny. Niniejszy artykuł stanowi przegląd różnych metod sporządzania recepturowych kropli do oczu z preparatów handlowych cyklosporyny, z omówieniem ich zalet i ograniczeń, jak również zawiera wskazówki dotyczące właściwego postępowania przy sporządzaniu takich kropli.

3

Fluid bed coating of minitablets and pellets with optimization of the process based on Taguchi method

100%

Turk M., Kawalec-Pietrenko B., Rybarczyk P., Sznitowska M.

Acta Poloniae Pharmaceutica - Drug Research

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2020

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vol. 77

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issue 1

161-173

EN

Small particles like pellets are coated in fluid bed systems. This method can be also feasible for minitablets but selection of optimal process parameters is complicated. The aim of the research was to optimize the coating process for minitablets and to compare the conditions with required for pellets. Minimum fluidization velocities (umf) for 2.0 and 2.5mm minitablets and for 0.7-0.8mm or 1.0-1.25mm pellets were determined experimentally. Additionally, the results were verified using the Ergun equation. The smallest relative differences between the calculated and experimental values of umf were obtained for P0.7 (4.6%), while the largest for MT2.5 (11.8%). To simplify optimization of the coating process, Design of Experiment (DoE) based on Taguchi method was employed. Selection of the best process parameters was based on the film thickness measurements for minitablets, while the sieve analysis was used for pellets to detect agglomeration. The best combination of process parameters resulted in uniform film thickness in minitablets, with RSD less than 15%, and the pellets batch containing only 0.25% of bonded particles. It was found that the largest impact on the uniform film deposition on minitablets had a spraying pressure, responsible for the size of coating mixture droplets. In case of pellets the most critical was the inlet air temperature. The presented research demonstrated that it was possible to achieve the best parameters of the coating process for minitablets and pellets by combining calculations of minimum fluidization velocity and Design of Experiment based on Taguchi method.

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2 Farmacja Polska

1 Acta Poloniae Pharmaceutica - Drug Research

2 2020

1 2019

3 Sznitowska M.

1 Gajewska M.

1 Jacyna B.

1 Kawalec-Pietrenko B.

1 Maciejewski B.

1 Rybarczyk P.

1 Turk M.

1 Wolska E. K.

Hydrożele w recepturze aptecznej leków dermatologicznych

Trudności w sporządzaniu recepturowych kropli do oczu z cyklosporyną A

Fluid bed coating of minitablets and pellets with optimization of the process based on Taguchi method