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Hard Shell Capsules in Clinical Trials
Published in Larry L. Augsburger, Stephen W. Hoag, Pharmaceutical Dosage Forms, 2017
Moji Christianah Adeyeye, Amusa Adebayo
In another related study, COLAL-PRED oral capsules were used in multicentered Phase III clinical trials involving 796 participants for the treatment of moderate acute ulcerative colitis. The 8-week randomized parallel study involved once-daily dosing of 40-, 60-, and 80-mg COLAL-PRED oral capsules, with prednisolone tablets as the active comparator. Colitis activity index and cortisol level were used as the endpoints of this safety and efficacy study. Although there were no differences in efficacy, the authors suggested that the safety profile of the test product was better than that of the comparator [46] COLAL-PRED has the potential to become the first bacteria-aided biomaterials and pH-sensitive polymeric film (BPSF)-coated delivery system approved for use in humans. Guar gum/Eudragit RS PO/S100 blend was used in coating hypromellose theophylline capsules using triethyl citrate as plasticizer and the dip coating method in another study [47]. The intent of the study was colon-delivery but there was no justification made in the report for colonic delivery of theophylline [14].
Nail Product Rheology
Published in Laba Dennis, Rheological Proper ties of Cosmetics and Toiletries, 2017
An important property of plasticizers to note is the ratio required to obtain flexibility. It is possible to use a lesser amount of a more efficient plasticizer, possibly affecting other properties to a smaller degree. On the other hand, the formulation becomes less tolerant to changes in plasticizer level. Many formulations therefore contain more than one plasticizer to enable the optimization of properties. Many formulations contain three or more plasticizers. Typical plasticizers used include dibutyl phthalate, camphor, and castor oil. The plasticization effect of the modifying resin is an important factor. Another plasticizer used in some conventional nail polishes is acetyl triethyl citrate. Diisobutyl adipate, butyl octyl adipate, N-ethyl toluene sulfonamide, butyl benzyl phosphate, and tricresyl phosphate (21), alkyl sulphonic esters of phenol (12), and others have been found in some specialty polishes.
Topical Formulations for Onychomycosis: A Review
Published in Andreia Ascenso, Sandra Simões, Helena Ribeiro, Carrier-Mediated Dermal Delivery, 2017
Barbara S. Gregorí Valdes, Carolina de Carvalho Moore Vilela, Andreia Ascenso, Joao Moura Bordado, Helena Ribeiro
Chouhan et al. [57] studied the influence of a permeation enhancer (hydroxypropyl-b-cyclodextrin or HP-p’-CD) in a terbinafine nail lacquer formulation. This formulation was composed of cellulose acetate and ethyl cellulose as film-forming polymers, triethyl citrate as plasticizer, and isopropyl alcohol and acetone as solvents. Formulations containing this enhancer demonstrated a higher flux than the control formulation in in vitro studies. The lacquer containing 10% (w/v) HP-b-CD showed maximum flux of 4.586 ± 0.08 gg/mL/cm2 as compared to the control flux of 0.868 ± 0.06 gg/mL/cm2, demonstrating its ability to enhance the transungual permeation of poorly soluble drugs [57].
Pre-plasticization of thermal binder facilitates processing and granule growth during melt granulation of gabapentin using co-rotating twin screw extruder
Published in Drug Development and Industrial Pharmacy, 2020
The remaining two plasticizers, stearic acid and triethyl citrate, were melt granulated at 0.075 g/min/rpm with gabapentin at 80% drug loading with 0%, 2%, or 5% (w/w) pre-plasticized HPC binder. The granules were assayed for degradation of Gaba to Gaba-L to confirm drug-plasticizer compatibility. The granules prepared with HPC pre-plasticized with stearic acid showed significantly greater degradation than those prepared with TEC (data shown in Supplemental Figure 1). This result may attributed to the pH-dependent stability of gabapentin, which shows an increased rate of degradation below pH 6.0 [21]. The introduction of an acidic excipient may have created a slightly acidic micro-environment during melt granulation, leading to a greater rate of degradation during processing. Triethyl citrate was therefore explored as the sole plasticizing agent in the subsequent studies.
Visualized analysis and evaluation of simultaneous controlled release of metformin hydrochloride and gliclazide from sandwiched osmotic pump capsule
Published in Drug Development and Industrial Pharmacy, 2020
Song Gao, Yanjun Chen, Rongfeng Hu, Wenjie Lu, Lingfei Yu, Jiayi Chen, Songlin Liu, Yuxing Guo, Qiang Shen, Bin Wang, Wenyou Fang
Gliclazide (GZ) was acquired from Ningbo Liminkang Pharmaceutical Co., Ltd (Zhejiang, China). Metformin hydrochloride (MH) was a kind gift obtained from Huainan Jiameng Pharmaceutical Co., Ltd (Anhui, China). Triethyl citrate (TEC) was purchased from Alddin Chemical Co., Ltd (Shanghai, China). Cellulose acetate (CA), Polyethylene glycol (PEG400, 4000, 6000), Carboxymethyl cellulose sodium (CMC-Na) and Sodium chloride (NaCl) were purchased from Sinopharm Chemical Reagent Co., Ltd (Shanghai, China). Polyvinyl pyrrolidone (PVP K90) was purchased from ISP Tech., Ltd. (Shanghai, China). Hydroxypropyl methyl cellulose (HPMC K100) was purchased from coloron Ltd. (USA). Polyoxy ethylene (PEO, wsr N10, MW 0.1 million, wsr N80, MW 0.2 million, wsr N205, MW 0.6million, wsr N1105, MW 0.9 million, wsr Coagulant, MW 6 million, and wsr 303, MW 7 million, wsr 301, MW 5 million) was gifted from Dow Chemical Co., Ltd. (Shanghai, China). All other solvents and chemicals were of the analytical grade.
On the plasticizing properties of divalproex sodium: physicochemical and spectroscopic characterization studies
Published in Pharmaceutical Development and Technology, 2019
Pinak Khatri, Dipen Desai, Tamara Minko
Traditional plasticizers such as triethyl citrate, dibutyl sebacate, and triacetin have been used widely, additionally certain active pharmaceutical ingredients (API) or excipients have been also shown to act as plasticizers. For instance, methylparaben (Wu and McGinity 1999), ibuprofen, chlorpheniramine maleate (CPM) (Wu and McGinity 1999; Siepmann et al. 2006) and metoprolol tartarate (Siepmann et al. 2006) were found to decrease the glass transition temperature of Eudragit RS films.