Formulation, Optimization and Evaluation of Ticagrelor Loaded Self Microemulsifying Chewable Tablets

Ticagrelor is a new generation Adenosine diphosphate receptor inhibitor drug which is highly lipohilic having poor aqueous solubility used in the treatment of Acute Coronary Syndrome and prevention of Thrombotic events like Stroke and Heart Attack. An approach has been made to develop Chewable tablets of drug loaded on Self-microemulsifying drug delivery systems (SMEDDS), screen suitable adsorbent for solidification of formulated SMEDDS and to study the effect of superdisintegrants in chewable tablets.

Methods:
On basis of Pseudoternary diagrams constructed for selected oil, surfactant and cosurfactant, SMEDDS formulation was formulated using Capmul MCM EP oil with surfactant (Cremophor RH 40) and co-surfactant (PEG 400) which was solidified using selected adsorbent. Chewable tablets were compressed by direct compression method using superdisintegrants.

Results:
IR Studies and DSC studies revealed compatibility and stability of drug in formulation. Compression blend containing Solidified SMEDDS possessed good flow and compressibility. Chewable tablets compressed using Soy Polysaccharides as super disintegrant showed least wetting and disintegration time, drug release of 97.68% within 30 min. Short term stability studies revealed no significant change in physical and chemical properties.

Conclusion:
These results suggest that the Ticagrelor loaded self microemulsifying chewable tablets can be a promising oral drug delivery system to improve the solubility and dissolution profile of Ticagrelor.

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Materials

Ticagrelor and Virgin coconut oil was purchased from Sigma Aldrich, Mumbai. Capryol PGMC(propylene glycol monocaprylate, type I), Mysine 35-1, Labrafil M 2125 C (linoleoyl macrogol-6 glycerides), Labrasol (caprylocaproyl macrogol-8 glycerides), Lauroglycol FCC (propylene glycol monolaurate, type I), Transcutol P (diethylene glycol monoethyl), Transcutol HP (Diethylene glycol monoethyl ether) were gifted from Gattefosse India Pvt. Ltd. Capmul MCME P (glycerylcaprylate/caprate), Capmul MCM C8 (Glyceryl Monocaprylate), Capmul PG-8 EP (Propylene Glycol Monocaprylate), Acconon MC8-2 EP (Caprylocaproyl Macrogolglycerides EP), Captex 170 EP (CocoylCaprylocaprate EP), Captex 200 P (Propylene Glycol Dicaprylocaprate EP) were gifted by IMCD India private limited, Mumbai.

Natural Vitamin E oil was gifted by Matrix Fine Science Pvt.Ltd. Aurangabad. Kolliphor EL and Kollisolv MCT-70 was gifted by BASF India Limited, Navi Mumbai India. Castor oil, Oleic acid, and Propylene glycol were procured from LobaChemiePvt. Ltd. Mumbai. Cremophor RH 40 (PEG-40 Hydrogenated Castor Oil), Tween 80 (Polyoxyethylene sorbitan monooleate) were purchased from HiMedia Laboratories Pvt. Ltd. Nashik. Tween 20, Tween 60, Isopropyl Alcohol, Methyl Alcohol were procured from S D Fine-Chem Limited. Mumbai, India. Spherolac 100 (sieved lactose monohydrate USP) and Sorbolac 400 (milled lactose monohydrate USP) was gifted by Signet excipients Pvt. Ltd. Mumbai. Vivasol GF LM (Croscarmellose Sodium), Emcosoy STS IP (soy polysaccharides), Vivapharm PVP K30 (Polyvinyl pyrrolidone) and Prosolv ODT G2(orally disintegrating tablet matrix) were gifted by Rettenmaier India PVT. LTD. A member of the JRS group. Pharmatose 200M (Lactose Monohydrate) was purchased from Lepid life sciences (P) Limited, Alwar, Rajasthan. MICCEL-101 (Microcrystalline Cellulose 101) and MICCEL-112 (Microcrystalline Cellulose 112) were gifted by Ankit pulps and boards PVT. LTD Mumbai, India. All the chemicals used were Pharmaceutical and analytical grades.

Veerendra KM, Masareddy RS, Patil AS, Bolmal U. Formulation, Optimization and Evaluation of
Ticagrelor Loaded Self Microemulsifying Chewable Tablets. Indian J of Pharmaceutical Education and Research.
2022;56(2s):s225-s234.
DOI: 10.5530/ijper.56.2s.93