Spectrochim Acta Part A Mol Biomol Spectrosc. 2021:19. Albendazole is practically insoluble in water.. An albendazole solubility experiment was carried out according to previous report [4]. Mean values were considered significantly different at p < 0.05. A new self-emulsifying formulation of mefenamic acid with enhanced drug dissolution. Development of a solidified self-microemulsifying drug delivery system (S-SMEDDS) for atorvastatin calcium with improved dissolution and bioavailability. The procedures used for sample preparation and handling were done within 24 h of blood sample collection. Albendazole SMEDDS chewable tablets were prepared using an optimized microemulsion system based on the procedures described above, with a target dose of 200 mg. Albendazole was dissolved in the microemulsion system at a concentration of about 0.4 mg/mL, corresponding to an albendazole dose of 40 mg. 160 mg of albendazole powder was further added to prepare the SMEDDS chewable tablets. In addition, we selected lactose for solidification, because of its popularity as a diluent in commercial products. Anthelminthic. Mol Pharm. 2c) by production of rough surface spherically shaped particles. Colloidal silica, a successful inexpensive hydrophobic carrier, requires common laboratory instruments to formulate as a vehicle for the preparation of solid SMEDDS [16,17]. The combination of albendazole SMEDDS with fast disintegrating strategies and their preparation as chewable tablets, similar to the market brand, are important for enhancing drug disintegration and improving dissolution of albendazole, thereby increasing bioavailability. Review of non-clinical toxicity and pharmacokinetics. 2016;16(9):49607. Solid state characterisation of a dry emulsion: A potential drug delivery system. The drug powders were each dispersed in 2 mL of distilled water and mixed homogeneously prior to oral administration. Therefore, spray drying specially by using Cremophor A25 (even with very low amounts) increased the solubility and dissolution rate of ABZ simultaneously. Results showed that the solubility and dissolution rate of ABZ were increased 1.8-2.6 folds and 3-25 folds, respectively. - 157.90.142.104. Cremophor RH40 is widely used as an emulsifying and solubilizing agent especially for albendazole [4]. The results indicated that sesame oil, soybean oil, Capmul PG8, Labrafac Lipophile WL1349, Cremophor RH40, Tween80, and PEG400 were the most effective in developing solvent mixtures because of the high solubility of albendazole (data not shown) in these vehicles. The flow properties of formulations showed that spray-drying worsen the flowability of ABZ from passible range (AOR = 41- 45) to poor range (AOR = 46-55) (21). Albendazole Dosage and Administration Dosage Dosing of Albendazole tablets will vary depending upon the indication. your institution, https://doi.org/10.1016/j.jobab.2020.03.005. Paulekuhn GS, Dressman JB, Saal C. Trends in active pharmaceutical ingredient salt selection based on analysis of the orange book database. Fig. The authors declare no competing interests. Excess quantities (20 mg) of the pure ABZ and formulations (containing an equivalent amount of 20 mg of ABZ) were dissolved in 2 mL of 0.1 N hydrochloric acid and stored in sealed micro tubes for 3 days at 37 0.5 C. The tablets were weighed again, and the percentage weight loss (friability) was calculated using the following formula: The disintegration test for the tablets was performed using a disintegration apparatus with discs (Pharma Test, model DIST3, Hainburg, Germany) described in USP36 [23] with six replicates for each tablet group. Horton J. Albendazole: A review of anthelmintic efficacy and safety in humans. Development of dispersible self-microemulsifying tablet of atorvastatin. This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms. Before J CO2 Util. Mean values with standard deviation of all physical parameters and drug content for all formulations are shown in Table 3. [2, 3] Consequently, it is poorly and erratically absorbed from the gastrointestinal tract. David S, Timmins P, Conway BR. Manin AN, Voronin AP, Drozd KV, Manin NG, Bauer-Brandl A, Perlovich GL. The flowability of formulations was assessed by determination of angle of repose (AOR). Tian Y, Jacobs E, Jones DS, McCoy CP, Wu H, Andrews GP. sharing sensitive information, make sure youre on a federal Before Physical mixing formulation without the granulating process (F3) was prepared in a similar manner to serve as controls. At 30 2 C/75 5% relative humidity, hardness was slightly increased, likely due to the absorbed moisture. Six measurements were taken and expressed as a mean value standard deviation. Albendazole (ABZ) is a benzimidazol derivative with a broad spectrum of activity against human and animal helminth parasites used in the treatment of echinococcosis, hydrated cysts, and neurocysticercosis. ACS infectious diseases. Patel, M., Mori, D., Dudhat, K. et al. 1Drug and Cosmetics Excellence Center, Walailak University, Thasala, Nakhon Si Thammarat 80161, Thailand; ht.ca.uw@as.eedawatta, 2School of Pharmacy, Walailak University, Thasala, Nakhon Si Thammarat 80161, Thailand, 3Drug Delivery System Excellence Center and Department of Pharmaceutical Technology, Faculty of Pharmaceutical Sciences, Prince of Songkla University, Hat Yai, Songkhla 90112, Thailand; ht.ca.usp@s.lopareet, 4Faculty of Pharmacy, Rangsit University, Pathumtani 12000, Thailand; ht.ca.usr@c.nomuran, 5Department of Pharmacology, Faculty of Sciences, Prince of Songkla University, Hat Yai, Songkhla 90112, Thailand; ht.ca.usp@s.nat. Cruz-Cabeza AJ. Particle size of liquid SMEDDS with and without 10% albendazole (mean SD, n = 3). Storage. Ten tablets of each category were accurately weighed and placed in a plastic chambered friability apparatus (Erweka, model TA220, Heusenstamm, Germany) described in USP36 [23]. Castro SG, Bruni SS, Lanusse CE, Allemandi DA, Palma SD. Mean plasma concentration/time profiles of albendazole sulfoxide after oral administration of albendazole at a dose of 50 mg/kg in SMEDDS chewable tablets formulation F2 (solid circles, n = 5), albendazole commercial tablets (open circles, n = 5) and albendazole powder (solid triangles, n = 5) in rats. Dong CL, Zheng SD, Liu YY, Cui WQ, Hao M-Q, Godspower BO, et al. A model-independent approach, dissolution efficiency (DE%), and a USP recommended time point approach namely the percentage of drug released at 30 min (F30min) were used to compare drug release profiles. Spectroscopic investigation on the mechanism of formation of molecular complexes of albendazole and trimethoprim with 2, 3-dichloro-5, 6-dicyano-1, 4-benzoquinone. Balakrishnan P., Lee B.J., Oh D.H., Kim J.O., Hong M.J., Jee J.P., Kim J.A., Yoo B.K., Woo J.S., Yong C.S., et al. The main mechanisms through which spray drying technique improve solubility and dissolution rate of drugs are a decrease in particles size and crystalline degree of the drugs (15). What Are Side Effects of Albenza? Improved particle wetting by adding small amount of surfactant may be responsible for observed results in the present study (14). The results of differential scanning calorimetry, Fourier-transform infrared spectroscopy, and powder X-ray diffraction suggested the formation of a new crystalline solid phase due to reaction between ABZ and organic acids. Therefore, change in crystalline degree of ABZ played the key role in dissolution behavior of the formulations. The content of this paper is extracted from the Pharm.D thesis (No. Investigated parameters of unprocessed albendazole and different solid dispersion formulation. Int J Pharma. official website and that any information you provide is encrypted It is slightly soluble in methanol, chloroform, ethyl acetate, and acetonitrile. Salt screening and characterization for poorly soluble, weak basic compounds: case study albendazole. Pharm Dev Technol. Bethesda, MD 20894, Web Policies We developed a chewable tablet (200 mg drug equivalent), containing a self-microemulsifying drug delivery system (SMEDDS), with oral disintegrating properties. Even decreasing the Cremophor/drug ratio to 1/100 could increase the ABZ solubility up to almost 2 folds (Table 1). Yalcin D, Ozcalik O, Altiok E, Bayraktar O. Inclusion in an NLM database does not imply endorsement of, or agreement with, The effect of cosolvents and pH on the aqueous solubility of albendazole are described here. FTIR spectra were obtained at a resolution of 4 cm-1 with a minimum of 256 scan per spectrum. Enhanced chemoprophylactic and clinical efficacy of albendazole formulated as solid dispersions in experimental cystic echinococcosis. HHS Vulnerability Disclosure, Help official website and that any information you provide is encrypted Diffractograms were run at scanning speed of 2 C/min and a chart speed of 0.022 C/min over 2- scale range of 2 C to 70 C. Preparation and characterization of a novel cocrystal of atorvastatin calcium with succinic acid coformer. Therefore, it was subjected to further in vivo studies for comparison with the commercial compressed chewable tablets. Introduction to amorphous solid dispersions. In this study, Cremophor A25 is introduced as a valuable excipient for improvement of dissolution rate of poorly soluble drugs (classe II and IV drugs of BCS) by simple, industrially scalable, one step, and cost-effective spray drying technique. La Operacin Deluxe tiene mucho -o todo- que ver con el final de Slvame, previsto para el prximo viernes 23 de junio. Seljak K.B., Ilic I.G., Gasperlin M., Pobirk A.Z. The mixture solutions of glacial acetic acid and water (1:1 v/v), containing excipients and drug were fed into the nozzle via a peristaltic pump sprayed at flow rate of 8 mL/min with the compressed air force of 75 L/h using a mini spray dryer (B-290, Bchi, Switzerland). Temperature was maintained at controlled room temperature (25 2 C) and humidity of 5060% with a 12 h light and dark cycle throughout the experiment. No human subjects or animals were used during this research work. 2019;19(3):6607. Different efforts have been made to enhance solubility and dissolution rate of ABZ such as preparation of oil in water emulsion, incorporation into liposomes, complexation with cyclodextrins, and preparation of solid dispersions (7,8). Complete dissolution was achieved from F3 in 30 min. Google Scholar. Other ingredients including milk powder, cocoa powder, sugar, and vanilla flavor powder were chosen for their good taste in chewable tablets. J Pharm Innov 17, 11481159 (2022). 8600 Rockville Pike Solubility. Npoje s vysokm obsahom antioxidantov, ako s vitamny C a E, preukzatene zlepuj erektiln funkciu tm, e brnia pokodeniu buniek, produkujcich oxid dusnat," hovor Pearlmanov. Results of angle of repose measurement showed that spry drying of ABZ caused an increase in the angle of repose and consequently a decrease in flowability of the powder. Albendazole falls into the biopharmaceutical classification system (BCS) class II category with a high permeability and low solubility. Oral bioavailability and lymphatic transport of pueraria flavone-loaded self-emulsifying drug-delivery systems containing sodium taurocholate in rats. Ten tablets of selected formulation were weighed and grounded to a fine powder, and a quantity equivalent to 200 mg albendazole (700 mg of powder) was introduced into a 100 mL volumetric flask and diluted with the mobile phase. Park JH, Choi HK. The dissolution rates of F2 was similar to F1, due to the complete solubilization of the albendazole in the microemulsion system. Crys Grow Des. The results of 1H NMR studies indicted the participation of protons attached to nitrogen atoms (N-H+) in the salt formation process. Selected formulations of the albendazole SMEDDS chewable tablets were packed in Alu-PVC blister packaging covered with aluminum foil, in order to block moisture and light, and kept under accelerated conditions (40 C/75% relative humidity (RH)), long-term stability conditions (30 C/75% RH), and at room temperature with ambient relative humidity following the Association of Southeast Asian Nations Guidelines the Stability of Drug Products according to climatic zone IVb [27,28]. By moisture absorption, phase separation, crystal growth or a change from metastable less crystalline to stable crystalline form can occur which results in the reduction of drug solubility on aging (17). Hasan N.M.Y., Almalki D.M., Althuwaybi M.J.K., Alshehri H.M. SMEDDS tablet: Compatability of solid SMEDDS using various pharmaceutical tablet excipients. Melting points and melting enthalpy of unprocessed ABZ and spray-dried ABZ were 222.26 C, 204.46 J/g and 219.8 C, 190.27 J/g, respectively, indicating a decrease by spray drying process. 2018;107(1):41925. Mody Government Pharmacy College, Polytechnic Campus, Near Ajidam, Rajkot, Gujarat, 360005, India, Mohini Patel,Dhaval Mori,Sunny Shah,Jayant Chavda&Ajay Patel, R.K. School of Pharmacy, R.K. University, Rajkot, Gujarat, India, You can also search for this author in The .gov means its official. In the case of sesame oil/PEG400/Tween80 system, the efficiency of emulsification was good when the concentration of the surfactant/co-surfactant was more than 60% v/v of the liquid SMEDDS formulation. Appearance of albendazole self-microemulsifying chewable tablets: (A) microemulsion absorbed from colloidal silica and (B) albendazole self-microemulsifying granules. 3 shows the diffraction pattern of unprocessed ABZ, spray-dried ABZ as well as physical mixture and spray-dried ABZ with SLS, lactose, and Cremophor A25. In fact, SMEDDS does not contain water in their composition, which enhances their chemical and physical stability. Cocrystal screening of hydroxybenzamides with benzoic acid derivatives: a comparative study of thermal and solution-based methods. Development and evaluation of a solid self-nanoemulsifying drug delivery system for loratadin by extrusion-spheronization. This is a preview of subscription content, access via In general, the drug content of active ingredients was set within the limit of 90110% of the labeled claim [23]. Colloidal silicon dioxide is non-porous silica with hydrophobic properties. 1998). Prashant R., Rakesh M., Tanaji N., Sushikumar P. Solubility and dissolution enhancement of albendazole by spherical crystallization. A significantly higher amount of drug release was observed in in vitro dissolution study from all the prepared salts compared to a pure drug in 0.1N HCl. Furthermore, among the investigated excipients, only SLS, glucose, and Cremophor A25 (at ratio of 1:1) showed better flow characteristics after spray drying (Table 1). Int J Pharm. Rahimpour Y, Hamishehkar H. Lactose engineering for better performance in dry powder inhalers. The microemulsion containing 20% sesame oil, 40% PEG400:Tween80 (2:1), and 40% water is shown in Figure 4. Formulation of lipid-based delivery systems for oral administration: Materials, methods and strategies. Furthermore, PEG400 and Tween80 are powerful solubilizing agents used in several dosage forms [32]. Spray-dried formulation containing SLS showed lower solubility than all formulations prepared with other excipients and even unprocessed drug which could be attributed to the interaction of sulphate moiety in SLS and amine group in ABZ (Fig. These soft materials were prepared using gelatin . Effects of solid carriers on the crystalline properties, dissolution and bioavailability of flurbiprofen in solid self-nanoemulsifying drug delivery system (solid SNEDDS), Tran T., Rades T., Mllertz A. Formulation of self-nanoemulsifying drug delivery systems containg monoacyl phosphatidylcholine and Kolliphar. Alternatively, the direct measurement of ABZ solubility in water gave 5. . Results of the XRD study of co-spray dried formulations with mannitol, sorbitol, sucrose, and glucose indicated same change in the crystallinity of ABZ after spray drying (data are not shown). Addition of mannitol, sorbitol, glucose, sucrose, and lactose to the spray-dried ABZ formulations did not further improve the solubility of ABZ (Table 1). The mixtures of surfactant and co-surfactant with water were prepared at ratios of 10:0, 9:1, 8:2, 7:3, 6:4, 5:5, 4:6, 3:7, 2:8, 1:9, and 0:10 (w/w). To improve the solubility and dissolution rate of ABZ, different classes of hydrophilic excipients such as sugars (lactose, sucrose, and glucose), polyols (mannitol and sorbitol), ionic surfactant (sodium lauryl sulfate) and non-ionic surfactant (Cremophor A25) were co-spray dried with ABZ. These CBD candies offer a simple and flexible . Incorporation of highly water soluble excipients in solid dispersions always enhances the chances of crystallization due to water uptake characteristics when comes in contact with the aqueous gastrointestinal fluids. The drug-containing oil phase was transferred into the surfactant and co-surfactant mixture under continuous mixing, vortexed and heated at 50 C in a sonicator until albendazole was completely dissolved. The enthalpy values of powders produced by co-spray drying of ABZ with SLS and Cremophor A25 were reduced dramatically, indicating the great change in crystallinity of ABZ structure during spray drying process (Table 2). Preparation and in vitro characterization of a eutectic based semisolid self-nanoemulsified drug delivery system (SNEDDS) of ubiquinone: Mechanism and progress of emulsion formation. 2b). Mechanism of action. Journal of Pharmaceutical Innovation 1998;87(5):5568. Pseudo-ternary phase diagrams were used for the selection of microemulsion area using water titration method. Characterization and recovery of tartaric acid from wastes of wine and grape juice industries. Appearance of microemulsion containing sesame oil, PEG400, Tween80 and water. Kller S., Nardin I., Markt R., Griesser J., Prfert F., Bernkop-Schnrch A. Self-emulsifying drug delivery systems: Design of a novel vaginal delivery systems for curcumin. Drug Dev Ind Pharm. Therefore, it is necessary to enhance dissolution of these drugs to ensure maximum therapeutic efficacy (1,2,3). government site. Data shown indicate mean standard deviation (SD). Kumar L, Amin A, Bansal A. Drug release studies were performed by USP type II apparatus for 90 min in 0.1 N hydrochloric acid (37 0.5 C) at 50 rpm according to US pharmacopeia (USP) recommendation (11). The filtrate was suitably diluted with the mobile phase prior to HPLC analysis as previously described. 2007;50(26):666572. Drug Dev Res. After a series of self-microemulsion formulations was selected from the ternary diagram of surfactants, co-surfactants, and oils, the solubility of albendazole was carried out by HPLC assay. Magnesium stearate (P.C. The average values of the disintegration time and standard deviations were calculated. The therapeutic response of albendazole (20 to 50%) in cases of echinococcosis is variable and difficult to predict (2, 8).Albendazole's poor intestinal absorption (<5%) (due to its low aqueous solubility) is probably a major determinant of the variable response rate ().In animal studies, the main strategy to enhance albendazole bioavailability was by that of increasing water and lipid . Aim: Solid dispersions using Poloxamer 407 as carrier were developed to improve albendazole (ABZ) solubility and dissolution profiles. The concentrations of albendazole and albendazole sulfoxide in the formulations and in plasma samples were determined using HPLC as previously reported with a modification [4,20,21,22]. To Improve the drug dissolution rate, several techniques have been developed and investigated such as particle size reduction, solid dispersion, inclusion complex formation, use of solubilizing agents, enhancement by surfactant systems, prodrug strategies and drug derivatization, lipid-based formulations, orally disintegrating tablets, self-emulsifying drug delivery system (SEDDS), and self-microemulsifying drug delivery system (SMEDDS) [7,8,9]. ABZ, a drug with very low solubility, were co-spray dried with different hydrophilic excipients to improve its solubility and dissolution rate. Surfactant and co-surfactant were mixed together in a separate test tube and mixed well under vortex, then heated to 60 C to mix properly. In all SMEDDS formulations, flow properties increased when incorporating the self-microemulsion system (F4). : a comparative study of thermal and solution-based methods pseudo-ternary phase diagrams used... 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