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Abstract

FORMULATION, DEVELOPMENT & EVALUATION OF NOVEL SUSTAINED RELEASE ORODISPERSIBLE TABLETS OF ROPINIROLE HCL BY SPRAY DRYING TECHNIQUE

Mahale Nitin B , Bankar Sandip K, Chaudhari Abhishek V, Battase Anil P, Chaudhari Sanjay R

ABSTRACT

Ropinirole HCl, a dopamine agonist used in the Paarkinsonism in reatless legs syndrome (RLS) is a highly water soluble drug (133 mg/ml).It is generally generally available as a conventional solid oral dosage form which is a major problem for the patients undergoing the dopamine therapy. The Parkinsonism patients taking Ropinirole HCl conventional tablet cannot swallow the dosage form due to reduced muscular activity, unavailability of water, dryness of mouth and dysphagia. The frequency of administration of this dosage form is minimum thrice a day due to lower dose (upto 8 mg) and shorter half life (5 hrs), so the problem arises in the number of doses. To overcome both these problems the sustained release orodispersible tablet dosage form of Ropinirole HCl is developed which will deliver the drug over a longer period of time. Microspheres of Ropinirole HCl were prepared by spray drying technique using the combination of hydrophilic and lipophillic polymers i.e. HPMC-K1M and Eudragit RL100 & Eudragit RS100 in drug:polymer ratio 1:9.The ODTs were prepared by direct compression of mixture containing microspheres formula F12 using crospovidone as a superdisintegrants, lactose and sodium saccharine as a sweetener. The novel formulation of SR-ODT of Ropinirole HCl (F12) showed acceptable hardness (3.3 Kp), friability (0.84 %) and disintegration time (26 sec).The microsphere of Ropinirole HCl showed an increasing trend of entrapment efficiency and in-vitro drug release. The in vitro drug release study suggests the sustained release of drug despite being highly water soluble.Scanning electron microscopy, differential scanning calorimetry and FT-IR study of the drug and formulation was carried out.

Keywords: Parkinsonism, Restless legs syndrome, microspheres, spray drying, orodispersible tablet.


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