ABITEC Corporation

Columbus, OH, United States

ABITEC Corporation

Columbus, OH, United States
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Bu P.,St. John's University | Narayanan S.,St. John's University | Dalrymple D.,ABITEC Corporation | Cheng X.,St. John's University | Serajuddin A.T.M.,St. John's University
European Journal of Pharmaceutical Sciences | Year: 2016

Purpose Caco-2 cells are used extensively for in vitro prediction of intestinal drug absorption. However, toxicity of excipients and formulations used can artificially increase drug permeation by damaging cell monolayers, thus providing misleading results. The present study aimed to investigate cytotoxicity of common lipid-based excipients and formulations on Caco-2 cells. Methods Medium-chain monoglycerides alone or in mixture with the surfactant Cremophor EL, with and without a medium-chain triglyceride, were prepared and incubated with Caco-2 cells from a series of culture stages with varying maturity. Cell viability was evaluated and cell membrane integrity assessed. Results Cytotoxicity of lipid-based formulations was influenced by the maturity of Caco-2 cells and formulation composition. One-day culture was most sensitive to lipids. When cultured for 5 days, viability of Caco-2 cells was significantly improved. The 21-day Caco-2 monolayers maintained the highest survival rate. Microemulsion formulations exhibited significantly less cytotoxicity than neat lipids or surfactant at all stages of cell maturity, and microemulsions containing 1:1 mixtures of monoglyceride and triglyceride appeared to be best tolerated among all the formulations tested. Mechanistically, the observed cytotoxicity was partially due to lipid-induced rupture of cell membrane. Conclusions Microemulsions of lipid-surfactant mixtures have less cytotoxicity than lipid alone. Maturity of Caco-2 cells renders significant resistance to cytotoxicity, and monolayers with 21-day maturity are more relevant to in vivo conditions and appear to be a more accurate in vitro model for cytotoxicity assessment. © 2016 Elsevier B.V.


The US Food and Drug Administration (FDA) recently issued guidance intended to curtail the use of medically important antibiotics in agricultural applications. In the wake of these recommendations, the veterinary medicine community has mobilized to define and commercialize effective alternative pathogen controls. In this article, we draw attention to the scope of the challenge by highlighting some of the most significant, pathogen-borne diseases relevant to food-producing animals. We also review the antimicrobial properties intrinsic to midchain triglyceride lipolysis products, and present the question: What is the untapped potential of these safe-for-consumption, environmentally benign, and mechanistically privileged antimicrobial natural products? © 2017 Drug Development & Delivery All rights reserved.


Prajapati H.N.,St. John's University | Dalrymple D.M.,ABITEC Corporation | Serajuddin A.T.M.,St. John's University
Pharmaceutical Research | Year: 2012

Purpose: To compare physiochemical properties of mono-, di- and triglycerides of medium chain fatty acids for development of oral pharmaceutical dosage forms of poorly water-soluble drugs using phase diagrams, drug solubility, and drug dispersion experiments. Methods: Phase diagrams were prepared using a monoglyceride (glycerol monocaprylocaprate: CapmulMCM® EP), a diglyceride (glycerol dicaprylate) and two triglycerides (glycerol tricaprylate: Captex 8000®; caprylic/capric triglycerides: Captex 355 EP/NF®) in combination with a common surfactant (PEG-35 castor oil: Cremophor EL®) and water. Psuedoternary phase diagrams using mixtures of monoglyceride with either diglyceride or triglyceride were constructed to determine any potential advantage of using lipid mixtures. Result: The monoglyceride gave microemulsion (clear or translucent liquid) and emulsion phases, whereas di- and triglycerides exhibited an additional gel phase. Among individual mono-, di- and triglycerides, the oil-in-water microemulsion region was the largest for the diglyceride. Gel phase region within diglyceride and triglyceride phase diagrams could be practically eliminated and microemulsion regions expanded by mixing monoglyceride with di- or tri-glycerides (1:1). Addition of a model drug, danazol, had no effect on particle sizes of microemulsions formed. Dispersion of drug in aqueous media from mixtures of mono- and diglyceride or mono- and triglyceride was superior to individual lipids. Conclusion: Systematic study on comparison of mono-, diand triglyceride of medium chain fatty acids will help formulators select components for optimal lipid-based formulation. © The Author(s) 2011.


Gumaste S.G.,St. John's University | Dalrymple D.M.,ABITEC Corporation | Serajuddin A.T.M.,St. John's University
Pharmaceutical Research | Year: 2013

Purpose: To develop tablet formulations by adsorbing liquid self-emulsifying drug delivery systems (SEDDS) onto Neusilin®US2, a porous silicate. Methods: Nine SEDDS were prepared by combining a medium chain monoglyceride, Capmul MCM EP, a medium chain triglyceride, Captex 355 EP/NF, or their mixtures with a surfactant Cremophor EL, and a model drug, probucol, was then dissolved. The solutions were directly adsorbed onto Neusilin®US2 at 1:1 w/w ratio. Content uniformity, bulk and tap density, compressibility index, Hausner ratio and angle of repose of the powders formed were determined. The powders were then compressed into tablets. The dispersion of SEDDS from tablets was studied in 250 mL of 0.01NHCl (USP dissolution apparatus; 50 RPM; 37 C) and compared with that of liquid SEDDS. Results: After adsorption of liquid SEDDS onto Neusilin®US2, all powders demonstrated acceptable flow properties and content uniformity for development into tablet. Tablets with good tensile strength (>1 MPa) at the compression pressure of 45 to 135 MPa were obtained. Complete drug release from tablets was observed if the SEDDS did not form gels in contact with water; the gel formation clogged pores of the silicate and trapped the liquid inside pores. Conclusion: Liquid SEDDS were successfully developed into tablets by adsorbing them onto Neusilin®US2. Complete drug release from tablets could be obtained. © 2013 The Author(s).


Patel N.,St. John's University | Dalrymple D.M.,ABITEC Corporation | Serajuddin A.T.M.,St. John's University
Journal of Excipients and Food Chemicals | Year: 2012

Solid self-emulsifying drug delivery systems (SEDDS) for medium chain triglycerides (Captex® 355, ABITEC) were developed using stearoyl polyoxyl glycerides (Acconon® C-50, ABITEC and Gelucire® 50/13, Gattefosse) as both solidifying and emulsifying agents. Different mixtures of the lipid and each solidifying agent were heated to 65°C until homogenously mixed clear liquids were formed. Probucol was dissolved as the model drug. The molten mass was then filled into hard gelatin capsules, which upon cooling to room temperature converted to a solid mass inside capsules. The triglyceride could be incorporated into the system to a concentration as high as 80% w/w, still maintaining the solid or semisolid consistency of the system. Powder XRD, DSC, microscopy (cross-polarization and confocal fluorescence techniques), dispersion test and particle size analysis of the solid systems with, and without, drug were conducted to characterize different formulations. The solidifying agents maintained their crystallinity in solid systems, while the lipids were interspersed in between crystalline regions. The drug remained solubilized in the lipid phase. The formulations dispersed almost completely in 2 hours with particle size of the dispersed lipid in the range of 250 to 500 nm when the lipid content in the formulation was up to 50% w/w. Thus, a novel method of developing solid formulations of liquid triglycerides by incorporating lipids in stearoyl polyoxyl glycerides has been developed. © IPEC-Americas Inc.


Trademark
Abitec Corporation | Date: 2012-06-26

Powdered high melting point vegetable oil fat for use as an emulsifier in the manufacture of foods, specifically used in confections and coatings as preventive of liquefaction of other fats at high temperature and intended to produce dry texture in materials in which it is used.


Trademark
Abitec Corporation | Date: 2012-06-26

Chemicals for use in the manufacture of goods, in the nature of fatty alkanolamides used as emollients, surfactants and builders in shampoo, hard surface cleaners, and assorted personal care, household, industrial and institutional items.


Trademark
Abitec Corporation | Date: 2012-06-26

Chemicals for use in the manufacture of goods in the nature of ethoxylated fatty amines and amine derivatives used as emulsifiers and surfactants in household, industrial and institutional applications for products such as lotions, shampoos, oil field, metalworking, and asphalt enhancers.


Trademark
Abitec Corporation | Date: 2012-06-26

Chemicals for use in the manufacture of goods in the nature of ethoxylated and nonionic compounds used as detergents, surfactants, emulsifiers, and wetting agents in household, industrial, institutional and personal care applications such as fabric treatment, personal care preparations, pulp and paper, and oil recovery.


Trademark
Abitec Corporation | Date: 2012-06-26

Chemicals for use in the manufacture of goods, in the nature of fatty quaternary ammonium compounds used for anti-static and softening of textiles, fibers, hard surfaces, personal care applications, and in household, industrial, institutional, personal care and paper industries.

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