Effect of formulation and process variables on lipid based sustained release tablets via continuous twin screw granulation: A comparative study

Kallakunta, Venkata Raman; Tiwari, Roshan V.; Sarabu, Sandeep; Bandari, Suresh; Repka, Michael A.

doi:10.1016/j.ejps.2018.05.007

Cited by 37 publications

(15 citation statements)

References 51 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…It can also be interpreted that as the number of C-atoms in the alkyl chain of the fatty acid of lipid increases, its hydrophobicity increases potentiating its release retardant property and minimizing its amount in forming the release retarding matrix. 45 These results are analogous with result of Abd-Elbary et al who had formulated lipid matrix tablet of Etodolac using sodium stearate as lipid matrix former.…”

Section: Discussionsupporting

confidence: 87%

Comparison of Release Retardant Effect of Some Novel Lipids by Formulating Sustained Release Tablet of BCS Class 1 Drug

Devi¹,

Sharma²,

Sharma³

et al. 2020

IJPER

View full text Add to dashboard Cite

Aim: The study was carried out with the objective of comparing the release retardant effect of some novel lipids by preparing sustained release tablets of highly watersoluble drug, theophylline. Methods: The tablets were a mixture of theophylline and each of the three novel lipids taken in different ratios (Compritol ATO 888, Precirol ATO 5, Dynasan 114) prepared by Direct compression method. Drug and novel lipids interaction was determined by FTIR spectroscopy and DSC while drug release from the sustained release tablets was studied using USP-ll dissolution apparatus. The release was analysed to determine the lipid showing the best retardant effect. It was also subjected to different kinetic models to evaluate the release kinetics and mechanism of release. Statistical analysis was done on in-vitro release data by ordinary one-way ANOVA to check for significant difference in release for different formulation. The hardness and other evaluation parameters of the tablets were within acceptable range. Results: FTIR and DSC showed no interaction between the drug and the lipids of the formulations (DC1 to DC9) and DC1 formulation showed the best sustained release in 12 hr. The result of release retardant effect given by the lipids is in the order dynasan < precirol < compritol. Conclusion: The study showed that Compritol ATO 888 (glyceryl behenate) was highly hydrophobic lipid and therefore showed best sustained release of water-soluble drug theophylline as compared to Precirol ATO 5 (glyceryl palmitostearate) and Dynasan 114 (glyceryl tri myristate) lipids.

show abstract

Section: Discussionsupporting

confidence: 87%

Comparison of Release Retardant Effect of Some Novel Lipids by Formulating Sustained Release Tablet of BCS Class 1 Drug

Devi¹,

Sharma²,

Sharma³

et al. 2020

IJPER

View full text Add to dashboard Cite

show abstract

“…C-888, due to its thermostable nature, was utilized to form HME matrices. C-888 melted at around 74 • C and extruded below its melting point at around 70 • C [4, [24][25][26]. There are several advantages of using C-888 as a processing aid instead of chemical plasticizers and other hydrophobic polymers.…”

Section: Hme Processing Methods and Carriers Screening Studiesmentioning

confidence: 99%

Development and Characterization of Sustained-Released Donepezil Hydrochloride Solid Dispersions Using Hot Melt Extrusion Technology

et al. 2021

Self Cite

View full text Add to dashboard Cite

The aim of this work was to develop the sustained release formulation of donepezil hydrochloride (DH) using the hot-melt extruded solid dispersion technique via the rational screening of hydrophobic carriers. Hydrophobic carriers with different physicochemical properties such as pH-independent swellability, low-permeability (Eudragit® RS PO (E-RS)), pH-independent non-swellability (ethyl cellulose N7 (EC-N7)), and the presence of lipids (Compritol® 888 ATO (C-888)) with or without pore-forming agents were used to achieve the sustained release profile of DH. Mannitol (MNT) was chosen as the temporary pore-forming agent. The thermal analysis showed that both the drug and C-888 preserved their crystallinity within a solid dispersion. During a dissolution test, MNT could generate pores, and the drug release rate was proportionally correlated to the MNT content. Tailoring of the ratio of C-888 and MNT in the formulations along with an appropriate extrusion temperature profile resulted in the modified release of DH, and a preferable release pattern was obtained under these conditions. C-888 was chosen for the further investigations to obtain tablets with a high integrity. The optimized tablets were compared to the marketed formulation of Aricept® in terms of drug release profiles. The optimized formulation showed the stable and sustained release behavior of extended release profile, which was close to the release behavior of Aricept® with good tablet characteristics. It was concluded that the hot-melt extrusion technique can be utilized for the manufacturing of DH sustained release tablets with improved tablet integrity and characteristics by co-processing the tablet excipient with DH/C-888.

show abstract

“…Since continuous technologies are heavily promoted by the authorities [7,8], intense R&D efforts are going into their possible industrial applications [9,10]. Numerous papers have been published based on the research conducted on Twin-Screw Granulators [11][12][13][14][15][16][17].…”

Section: Introductionmentioning

confidence: 99%

Continuous Manufacturing of Homogeneous Ultralow-Dose Granules by Twin-Screw Wet Granulation

Démuth

Fülöp

Kovacs

et al. 2020

Period. Polytech. Chem. Eng.

View full text Add to dashboard Cite

Homogeneous ultralow-dose (30 mg) tablets were prepared from perfectly free-flowing granules manufactured by continuous Twin-Screw Wet Granulation. The gravimetrically fed mixture of lactose and potato starch of low particle size was successfully agglomerated and the size enlargement technology proved to be very robust. Since the incorporated drug was dissolved in ethanol-based granulation liquid, the resulting homogeneity largely depended on the dosing of the applied liquid administering units.A peristaltic pump generated higher deviation of the drug content in tablets (Relative Standard Deviation (RSD): 7.7 %) compared to a syringe pump (RSD: 2.3 %) or a piston pump (RSD: 4.6 %). This is due to the pulsation of the liquid flow generated by the peristaltic pump according to the real-time measured mass of the fed liquid. A good correlation was found between the RSD of the liquid mass flow (calculated from the recorded masses) and the RSD of the drug content. Based on the results, the goodness of Content Uniformity, as the most relevant critical quality attribute of low-dose products, was determined by the characteristics of the applied dosing units. The feeding characteristic of the different pumps could be easily measured by the introduced balance-based method and therefore, the applicability of the pumps could be evaluated.

show abstract

Effect of formulation and process variables on lipid based sustained release tablets via continuous twin screw granulation: A comparative study

Cited by 37 publications

References 51 publications

Comparison of Release Retardant Effect of Some Novel Lipids by Formulating Sustained Release Tablet of BCS Class 1 Drug

Comparison of Release Retardant Effect of Some Novel Lipids by Formulating Sustained Release Tablet of BCS Class 1 Drug

Development and Characterization of Sustained-Released Donepezil Hydrochloride Solid Dispersions Using Hot Melt Extrusion Technology

Continuous Manufacturing of Homogeneous Ultralow-Dose Granules by Twin-Screw Wet Granulation

Contact Info

Product

Resources

About