Sıla Gülbağ Pınar

Objective: To detect the presence of glass fragments that may occur during the breaking of glass ampoules. Materials and Methods: In this study, one hundred 5 mL commercially available sterile water ampoules and those prepared manually in the laboratory were opened under normal conditions, and the liquid inside the ampoules was examined for glass particle contamination. The ampoules were opened by nurses according to their usual practices. Four groups, each of which has 25 ampoules, were formed as follows: commercial ampoule with a needle and without a needle, and manually prepared ampoule with a needle and without a needle. The liquid inside the ampoule was drawn with a needle and a normal tip. The presence of glass particles was examined with scanning electron microscopy to determine their size and quantity. Results: According to the results obtained, glass particles of different sizes were detected in all groups (52.24 µm to 746.6 µm). It was observed that there were still particles in the needle groups, although they were smaller in size. Conclusion: The entry of glass particles into the circulatory system can lead to serious pathophysiological effects at both acute and chronic levels, especially in critically ill patients and neonates requiring intravenous injections. Such complications are thought be prevented by replacing all ampoules, especially those to be administered IV, with materials that will not cause microfractures or small vials.

With the increasing influence of modern life, changes in dietary habits, and rising health awareness, vitamin, mineral, and essential amino acid supplements are frequently used, particularly in children and specific patient groups, as well as adults, to strengthen the immune system, protect bone health, and improve quality of life. Oral administration is frequently preferred for food supplements due to its advantages, such as being non-invasive, simple, and safe, and its ability to achieve the desired effect with frequent dosing. Gummy tablets have become a popular dosage form in recent years, especially in the field of vitamins and food supplements, due to their suitable taste, availability in different sizes and shapes, and low cost. In this study, new gummy tablets containing vitamin C, vitamin D, and arginine for oral use as food supplements were developed using a heating-pouring-cooling method. Two different gelling polymers (gelatin and gum arabic) were used, with a plasticizer (propylene glycol), a sweetener (aspartame), a flavoring agent (orange flavor), and a preservative (methyl paraben). Morphological controls, weight, diameter, and thickness measurements, dispersion time in distilled water, artificial saliva, and gastric fluid, as well as pH were performed on the gummy tablets. Based on the characterization studies, the optimum formulation was determined to be CDAGummyF4. CDAGummyF4 showed 1.53±0.03 grams of weight, 16.18±0.35 mm of diameter, 11.90±0.29 mm of height, 37 seconds of disintegration in distilled water, 70 seconds of disintegration in saliva, 54 seconds of disintegration in gastric fluid, and 4.45±0.00 pH. In conclusion, it is foreseen that gummy tablet formulations containing a combination of vitamin C, vitamin D, and arginine will be further developed through in vitro and in vivo studies.

Objectives: This study aimed to develop nanosuspensions (NSs) of cyclosporine A (CycA) using a top-down technology [high-pressure homogenization-(HPH)] for oral administration. Materials and Methods: Formulas were prepared using different ratios of hydroxypropyl methylcellulose (HPMC) (1% and 0.5%) and sodium dodecyl sulfate (SDS) (1%) to improve the solubility of CycA. The HPH method was optimized by investigating the effects of critical formulation parameters (stabilizer ratio) and critical process parameters (number of homogenization cycles) on the particle size (PS), polydispersity index (PDI), and zeta potential (ZP) of NS using the Design of Experiment (DoE). After lyophilization, differential scanning calorimetry, X-ray diffraction, fourier-transform infrared spectroscopy, and morphological evaluation with scanning electron microscopy were performed. Stability studies were conducted at 4 degrees C and 25 degrees C storage conditions. The solubility of the optimum CycA NS was investigated by comparing it with a coarse CycA powder and a physical mixture (PM). In vitro dissolution studies were conducted in four media using United States Pharmacopeia apparatus I. Results: PS, PDI, and ZP values for the NS were approximately 250 nm, 0.6, and 35 mV, respectively. Under storage conditions, the CycA NS exhibited significant physical stability at both 4 degrees C and 25 degrees C for 9 months. The solubility of CycA was improved 1.9 and 1.4 times by NS in the presence of CycA powder and PM, respectively. CycA NS exhibited higher dissolution than CycA coarse powder in 0.1 N HCl, fasted simulated intestinal fluid, and fed simulated intestinal fluid. Conclusion: CycA NS was successfully developed using the DoE approach with the HPH method with HPMC:SDS combination in a 1:0.5 ratio, and the solubility and dissolution of CycA in the NS were improved.

Nanosuspensions (NSs), which are nanosized colloidal particle systems, have recently become one of the most interesting substances in nanopharmaceuticals. NSs have high commercial potential because they provide the enhanced solubility and dissolution of low-water-soluble drugs by means of their small particle sizes and large surface areas. In addition, they can alter the pharmacokinetics of the drug and, thus, improve its efficacy and safety. These advantages can be used to enhance the bioavailability of poorly soluble drugs in oral, dermal, parenteral, pulmonary, ocular, or nasal routes for systemic or local effects. Although NSs often consist mainly of pure drugs in aqueous media, they can also contain stabilizers, organic solvents, surfactants, co-surfactants, cryoprotectants, osmogents, and other components. The selection of stabilizer types, such as surfactants or/and polymers, and their ratio are the most critical factors in NS formulations. NSs can be prepared both with top-down methods (wet milling, dry milling, high-pressure homogenization, and co-grinding) and with bottom-up methods (anti-solvent precipitation, liquid emulsion, and sono-precipitation) by research laboratories and pharmaceutical professionals. Nowadays, techniques combining these two technologies are also frequently encountered. NSs can be presented to patients in liquid dosage forms, or post-production processes (freeze drying, spray drying, or spray freezing) can also be applied to transform the liquid state into the solid state for the preparation of different dosage forms such as powders, pellets, tablets, capsules, films, or gels. Thus, in the development of NS formulations, the components/amounts, preparation methods, process parameters/levels, administration routes, and dosage forms must be defined. Moreover, those factors that are the most effective for the intended use should be determined and optimized. This review discusses the effect of the formulation and process parameters on the properties of NSs and highlights the recent advances, novel strategies, and practical considerations relevant to the application of NSs to various administration routes.

Amaç: Herpes simpleks labialis (uçuk) tedavisinde kullanılmak üzere ‘Asiklovir’ etkin maddesi içeren dudak balmı formülasyonunun geliştirilerek, mevcut tedavilerdeki bazı olumsuzlukların giderilip, uyunç sorunlarının ortadan kaldırılması ve ekonomik yöntemlerle kolay hazırlanışa sahip yeni bir formülasyonun tedaviye kazandırılmasının yanı sıra geleneksel majistral hazırlama yöntemlerine değer katılması amaçlanmıştır. Materyal-Metot: Asiklovir etkin maddesi ile kakao yağı, balmumu, lanolin ve karnauba mumu olmak üzere dört çeşit sıvağ ve çeşitli yardımcı maddelerin eşliğinde supozituvar hazırlama yöntemlerinden biri olan eritme metodu kullanılarak, 4 farklı sıvağdan oluşan 3 farklı formülasyon ve her bir formülasyondan 20 adet dudak balmı geliştirilmiştir. Son 2 sıvağ ile tüm denemelere rağmen kullanıma uygun bir formülasyon hazırlanamaması sebebiyle bu iki sıvağ kombine edilerek yeni bir formülasyon oluşturulmuştur. Her bir formülasyon tipinden oluşturulan 20 adet dudak balmı üzerinde morfolojik kontroller, ağırlık sapması kontrolü, erime derecesi kontrolü, kırılma ve mekanik dayanıklılık tayini gibi kontroller gerçekleştirilmiştir. Bulgular: Her bir formülasyon tipi üzerinde gerçekleştirilen kontroller sonucu tüm formülasyonların tekdüze bir ağırlığa sahip oldukları, morfolojik olarak homojen dağılım gösterdikleri, erime derecelerinin insan dudak yüzey sıcaklığından yakın derece fazla olduğu bulguları elde edilmiş, fakat kırılma ve mekanik dayanıklılık kontrolünde birbiriyle uyumlu sonuçlara ulaşılamamıştır. Sonuç: Sonuç olarak en optimum özellik gösteren formülasyon tipinin kakao yağıyla hazırlanan formülasyon olduğuna karar verilmiş, günlük hayatta kullanım kolaylığı sunan, kozmetiği iyi, hoş kokulu, antiviral özellik gösteren dudak balmı formunda bir formülasyon elde edilmiştir.

It is known that boric acid (BA) exerts it antioxidant and anti-inflammatory effects by activating the activating transcription factor 4 (ATF4) and nuclear factor-erythroid 2-related factor 2 (Nrf2) pathway. This pathway has been reported to control antioxidant status in the eye. The aim of this study was to investigate the possible preventive effects of boric acid administration on oxidative damage and corneal neovascularization (CNV). Sixteen adult female Wistar albino rats were divided into two groups: (I) control (n = 8); the CNV model was applied to the right eye of the rats, and the left eyes were used as healthy controls. (II) CNV + BA (n = 8): After the CNV model was applied to the right eyes, a single subconjunctival dose (0.05 mL) of 0,018 g/mL BA was injected into the right and left eyes of the rats. Biochemical, histopathological, and immunohistochemical analyses were performed. Moderate VEGF positivity was observed in the vessels of the CNV group, a decrease in vessel proliferation, and weak VEGF positivity in the CNV + BA group. The TAS level in the CNV + BA group was significantly higher than that in the other groups. The TOS level was significantly higher in all groups than it is in the control group. The OSI value was increased in all groups when compared to the control group, but only the CNV and BA groups were statistically significant. BA not only reduced alkaline-induced corneal damage histologically but also showed a protective effect on oxidative stress biochemically.

Cyclosporine A is a calcineurin inhibitor and is usually used as an immunosuppressant medication. The main purpose of this study is to develop nanosuspension of polypeptide cyclosporine A by using the wet milling method for oral administration. Cell culture studies were also performed with human intestinal Caco-2 cell lines. Hydroxypropyl methylcellulose and sodium dodecyl sulfate were used as stabilizers in nanosuspension. In vitro characterization studies such as fourier transformed infrared analysis and morphological imaging with scanning electron microscopy have been carried out with obtained cyclosporine A nanosuspension. The particle size, particle size distribution, and zeta potential values ​​of the nanosuspension were measured approximately 400 nm, 0.4, -25 mV, respectively. The solubility of cyclosporine A was increased 4.5 times in nanosuspension compared to the coarse cyclosporine A powder. As a result of cytotoxicity studies conducted with different concentrations, it was decided to conduct permeability studies at a dose equivalent to 150 µg/mL cyclosporine A. Permeation studies have shown that the nanosuspension increases cyclosporine A transport by 5 and 1.5 times, respectively, compared to coarse powder and commercial product.