Formulation Design, Development and In-Vitro Evaluation of Molnupiravir Gastroretentive Microspheres

Madhiyalagan, S (2021) Formulation Design, Development and In-Vitro Evaluation of Molnupiravir Gastroretentive Microspheres. Masters thesis, P.G.P. College of Pharmaceutical Sciences and Research Institute, Namakkal.


Download (2MB) | Preview


The present study involves formulation and evaluation of sustained release floating microspheres of Molnupiravir sulphate. Endeavour‟s with respect to floating mechanism are inculcated in the formulation to achieve longer stay of microsphere in stomach which happen to better site of absorption for the selected drug. Preformulation studies involving organoleptic bulk density, tapped density, angle of repose, compressibility of index, hausner ratio, melting point range, pH, solubility were carried out as per IP specification. Drug excipient compatibilities were carried out and evaluation and FT-IR, SEM. This showed no significant change in any way to the Mixture. Different polymers like sodium alginate, sodium carboxy methyl cellulose, HPMC K4M, HPMC K100M were utilized in the trials. All the physical evaluations are carried in preformulation studies were carried out on all the three different polymers utililized. All the formulations exhibited values within the acceptable range. Microspheres were evaluated for buoyancy studies, drug entrapment efficient. Release studies were carried out in 0.1N HCL for 12 hours. Evaluated samples for all the four polymer system. Results indicated that formulation F7, gave 90.12 % release up to 12 hrs which is formulated with HPMC K100M and HPMCK4M combination. Assay was carried out for formulation F7 and was found to be 88.69 %. The mechanism of drug release from microspheres follows Non-Ficknian release. Remaining formulations gave fluctuating release profiles. The formulation F7 was considered to be better among the trails accomplished. CONCLUSION: The ultimate goal for sustained drug release is to maximize therapeutic activity while minimizing the negative side effects of the drug. In this regard, floating microspheres have emerged as a novel drug delivery system to treat HIV with Molnupiravir sulphate. The type of polymer affects the drug release rate and the mechanism. Polymer swelling is crucial in determining the drug release rate and is also important for flotation. A lesser FLT and a prolonged floating duration could be achieved by using different polymer combinations. In this study sustained release Floating Microsphere approach for Molnupiravir purposes that with hydrophilic polymers the GI retention can be enhanced and reduce frequency of dosing, thereby minimizing the occurrence of side effects, site specificity, increase the effectiveness of the drug and better patient compliance This gives a signal to extending this approach to similar combinations of drugs used in clinical practice so as to improve bioavailability of poorly absorbed drugs in GIT. When these floating microspheres compared to other floating dosage forms like floating tablets have bulk density less than gastric fluid and so remain buoyant in the stomach for prolonged period of time and these are used as multiunit dosage form and drug release optimization and show efficiency level. So, Sustained release floating microspheres of Molnupiravir may provide a convenient dosage form for achieving best performance and release and show good bioavailability.

Item Type: Thesis (Masters)
Additional Information: 261911452
Uncontrolled Keywords: Formulation Design, Development, In-Vitro Evaluation, Molnupiravir Gastroretentive Microspheres.
Subjects: PHARMACY > Pharmaceutics
Depositing User: Subramani R
Date Deposited: 01 Nov 2022 17:33
Last Modified: 01 Nov 2022 17:33

Actions (login required)

View Item View Item