Novel coprocessed excipients composed of lactose, HPMC, and PVPP for tableting and its application

Wang, Songtao; Li, JinZhi; Lin, Xiao; Feng, Yi; Kou, Xiang; Babu, Sreehari; Panicucci, Riccardo

doi:10.1016/j.ijpharm.2015.03.069

Cited by 48 publications

(29 citation statements)

References 11 publications

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“…Research into co-processing of excipients has yielded products with diverse functionalities and performance attributes. These functionalities include orally disintegrating ability [6,7], improved dilution potential [8], rapid disintegration [9], enhanced direct compression functionality [10], multifunctional excipient [4,8], improved tabletability [11], and improved dispersibility [12].…”

Section: Introductionmentioning

confidence: 99%

Impact of binder as a formulation variable on the material and tableting properties of developed co-processed excipients

et al. 2019

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The functionality of a co-processed excipient is usually derived from its composition and the proportion of each excipient that is incorporated to yield a composite excipient. The aim of this study was to assess the impact of binder as a formulation variable on the material and tableting properties of developed co-processed excipients containing gelatin (SGS) and microcrystalline cellulose (SMS) as binders respectively in the same proportion. Two co-processed excipients, SGS and SMS were generated by combining tapioca starch (90%), gelatin or microcrystalline cellulose (7.5%) and colloidal silicon dioxide (2.5%) using the co-fusion method. Particle size analysis and morphological assessment were carried out by light microscopy and scanning electron microscopy (SEM) respectively. DSC analysis was performed to evaluate the thermal behaviour of both materials and flow properties were assessed by measuring parameters like angle of repose, bulk and tapped densities, Carr's index and Hausner's ratio. Compaction behaviour of both materials was determined using Heckel and Walker equations and the compressibility-tabletability-compactibility (CTC) profile for each material was obtained. Particulate and bulk-level properties of SGS and SMS revealed spherical-shaped, free-flowing powders characterized by a glass transition event typical of amorphous polymers. Compaction analysis demonstrated greater degree of plastic deformation with SMS resulting in better tableting properties with respect to tensile strength and disintegration time. The outcome of the study shows that the choice of binder used in the formulation of a co-processed excipient plays a crucial role in defining the material and tableting properties of the co-processed excipient.

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Section: Introductionmentioning

confidence: 99%

Impact of binder as a formulation variable on the material and tableting properties of developed co-processed excipients

et al. 2019

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“…(Nachaegari and Bansal 2004;Rojas et al, 2012). A combination of a plastic and brittle deforming material produces a co-processed excipient with desirable attributes for tableting (Wang et al, 2015). Many co-processing methods have been employed, including spray drying (Chauhan et al, 2016;Rojas and Kumar, 2011;Sharma et al, 2015), codrying (Mshelia et al, 2015;Olowosulu et al, 2011) wet massing, spheronisation, melt extrusion (Goyanes et al, 2011), co-precipitation (Kittipongpatana and Kittipongpatana 2011), co-grinding (Adeoye and Alebiowu, 2014a;Katsuno et al, 2013), wet-, dry-and spray-granulation (Daraghmeh et al, 2010) and coprocessing by crystal coating (Vanhoorne et al, 2014) among which spray drying is the most widely used and successful strategy (Rojas et al, 2012).…”

Section: Research Articlementioning

confidence: 99%

Comparative analysis of co-processed starches prepared by three different methods

Apeji¹,

Aluga²,

Olayemi³

et al. 2017

British Journal of Pharmacy

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Co-processing is currently of interest in the generation of high-functionality excipients for tablet formulation. In the present study, comparative analysis of the powder and tableting properties of three co-processed starches prepared by three different methods was carried out. The co-processed excipients consisting of maize starch (90%), acacia gum (7.5%) and colloidal silicon dioxide (2.5%) were prepared by co-dispersion (SAS-CD), co-fusion (SAS-CF) and co-granulation (SAS-CG). Powder properties of each co-processed excipient were characterized by measuring particle size, flow indices, particle density, dilution potential and lubricant sensitivity ratio. Heckel and Walker models were used to evaluate the compaction behaviour of the three co-processed starches. Tablets were produced with paracetamol as the model drug by direct compression on an eccentric Tablet Press fitted with 12 mm flat-faced punches and compressed at 216 MPa. The tablets were stored at room temperature for 24 h prior to evaluation. The results revealed that cogranulated co-processed excipient (SAS-CG) gave relatively better properties in terms of flow, compressibility, dilution potential, deformation, disintegration, crushing strength and friability. This study has shown that the method of coprocessing influences the powder and tableting properties of the co-processed excipient.

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“…They are rarely introduced to the market probably because discovering novel excipients is challenging or due to the modest profit. Novel excipients can be produced from one of the following routes: new chemical entities developed as further excipients, new grades of existing excipients, or new combinations of existing excipients (Wang et al, 2015).…”

Section: Introductionmentioning

confidence: 99%

“…The characteristics and tabletting properties of co-processed excipients with multiple functions are superior to those of a single substance or physicallymixed excipients concerning compatibility, intrinsic flow, lubricating efficiency, binding properties, and blending properties (Rojas and Kumar, 2011). Meanwhile, as an alternative to preparations of co-processed compressible powder mixture, the spray drying method is reportedly able to improve the compression properties of hypromellose and α-lactose monohydrate as a binder (Mužíková et al, 2014), with erythritol, mannitol, various maltodextrins, crospovidone, colloidal silicon dioxide, polyoxyethylene 20 sorbitan monooleate (Gonnissen et al, 2008), HPMC, lactose, and PVPP (Wang et al, 2015).…”

Section: Introductionmentioning

confidence: 99%

Formulation of Chlorpheniramine Maleate Tablets Using Co-Processed Excipient as a Filler and Binder

Syukri

Romdhonah

Fazzri

et al. 2019

J.Pharm.Sci.Community

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Co-Processed Excipient (CPE) is technological innovation for tablet preparation through the direct compression method with a quick and straight forward manufacturing process because it improves the compressibility and flowability. This research aimed to formulate and evaluate of chlorpheniramine maleate tablets using spray dried CPE as filler and binder. The spray dried CPE containing MCC PH 101, and Kollidon® K30 was made into tablets through a direct compression method. Meanwhile, Ludipress® and Avicel® PH 102 were used as filler-binder comparators. All the prepared tablet formulations were then evaluated for weight variation, hardness, friability, disintegration time, content uniformity of active ingredient, and dissolution test. The physical properties of tablets with CPE as a filler and binder produced an average weight of 151.65 ± 1.53 mg, 5.92 ± 0.38 kg of hardness, 0.06 ± 0.051% friability, 520.00 ± 2.00 seconds of disintegration time, and 99.24 ± 0.15% content uniformity of active ingredient. The comparators indicated better disintegration time than CPE (p<0.05), while the dissolution test showed that more than 80% (Q) of the amount of active ingredient was dissolved in 30 minutes. CPE could be successfully used to prepare tablet dosage form, and the tablets had fulfilled the standards of pharmacopoeia.

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Novel coprocessed excipients composed of lactose, HPMC, and PVPP for tableting and its application

Cited by 48 publications

References 11 publications

Impact of binder as a formulation variable on the material and tableting properties of developed co-processed excipients

Impact of binder as a formulation variable on the material and tableting properties of developed co-processed excipients

Comparative analysis of co-processed starches prepared by three different methods

Formulation of Chlorpheniramine Maleate Tablets Using Co-Processed Excipient as a Filler and Binder

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