EVALUATION OF
FLOATING PULSATILE DRUG DELIVERY SYSTEM
Submitted By
DEPARTMENT OF PHARMACEUTICS
BENGALURU INSTITUTE OF PHARMACY EDUCATION AND RESEARCH,
KOGILU MAIN ROAD, YALAHANKA, BENGALURU-64
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
KARNATAKA, BENGALURU.
ANNEXURE II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
5. TITLE OF TOPIC
The objective of present investigation was to prepare and evaluate a floating pulsatile drug
delivery system of metoprolol tartrate. The prepared floating pulsatile delivery system
consisted of three different parts: a core tablet, containing the active ingredient, an erodible
outer shell and a top cover buoyant layer. The rapid release core tablet (RRCT) was
prepared by using superdisintegrants along with active ingredient. Dry coating of optimized
RRCT was done by using different grades of hydroxy propyl methyl cellulose (HPMC) E5,
E15, and E50 and upper most buoyant layer was prepared withHPMC K15M and sodium
bicarbonate. Developed formulations were evaluated for their physical characteristics, drug
content, in vitro disintegration time, in vitro drug release profile (lag time), floating lag
time, floating time and in vivo X-ray study. On the basis of these evaluation parameters it
was found that optimized floating pulsatile release formulation (FPRT) F9 showed floating
lag time of 4 min, floating time of 12 hrs and release lag time of 6 hrs. The F9 formulation
showed compliance with chronotherapeutic objective of hypertension.2
1. Bulgarelli E et al., have formulated hydrophilic casein/gelatin beads using three different
cross-linker solvent compositions. The microspheres so obtained were studied for degree of
cross-linking comparing with the results of swelling process and degradation rate. It was
observed that the cross-linker solvent composition influences the penetration rate through
the matrix of the cross-linker, thus controlling the homogenicity of the matrix cross-linking.4
6. Anil K Anal, et al., have developed ionotropic cross-linked chitosan microspheres for
controlled release of Ampicillin. The beads were prepared with pentasodium
tripolyphosphate cross-linked chitosan microspheres having high acid resistance for
controlled release of Ampicillin. The microspheres were produced by emulsification and
spray drying method. The microspheres were characterized for their particle size, stability
and drug release patterns. The results indicated that the microspheres had size less than
10m and entrapment of Ampicillin was found to be 80%.9
10. Das M K , el al, have prepared Furosemide loaded alginate microspheres using ionic
cross linking technique, with the incorporation efficiency of 65% to 93%. The effect of
sodium alginate concentration, cross linking agent and drying condition was evaluated with
respect to entrapment efficiency, particle size, surface characteristics and invitro release
behaviors. They found that the mean particle size and entrapment efficiency varied with
change in various formulation parameters and at the same time gave sustained release of
drug from the microsphere.13
2. Time-lagged coating of floating core tablets for pulsatile release of drug coating solutions
of ethyl cellulose (rupturable polymer) combined with hydroxypropyl methyl cellulose
(erodible polymer) were prepared in isopropyl alcohol. The weight ratios of ethyl cellulose
(Aqualon EC N10) to hydroxypropyl methyl cellulose (Methocel E15) were 60:40%,
75:25% and 90:10% (w/w) based on the experimental design. The solution was plasticized
7. with triethyl citrate (20%, w/w, with respect to dry polymer), and then talc was added as
glidant (5%, w/w, related to dry polymer). The homogeneous dispersion was gently stirred
throughout the coating process. The polymer solution was sprayed onto the core tablets in a
conventional pan coating apparatus (Pharma R & D Coater, VJ Instruments Pvt. Ltd., India)
till the desired weight gain (5%, 10% and 15%, w/w). Coating conditions are maintained. At
each stage the coated tablets were further dried in the coating pan for 15min at 40 C. The
tablets were then placed in the oven at 40 C for 2h to remove the residual solvent
2. Stability studies.
8. 7.3 Does the study require any investigations or interventions to be Conducted on patients or
other humans or animals? If so, please Describe in brief.
Not applicable
7.4 Has ethical clearance been obtained from your institute in case 7.3?
Not applicable.
List of references:
1. Badve, S Sher P, Korde A, Pawar, A.P. Development of hollow/porous calcium pectinate
beads for floating-pulsatile drug delivery. Eur. J. Pharm. Biopharm 2009;65:8593.
2. Anuradha k.salukhe* ,Remeth J. Dias, Kailas K. Mali, Niranjan S.Mahanjan and
Vishwajeet S. Ghorpade . Formulation & Evalution of floating pulsatile drug delivery
system of Metoprolol tartrate Der Pharmacia letter 2011;3(3):147-60
3. Azahar Danish khan *,Meenakshi Bajpai floating drug delivery system ,An Overview
Inter J of pharm Tech res 2008;2(4):2497-505.
4. Basit, A., Lacey, L. Colonic metabolism of ranitidine: implications for its delivery and
absorption. Int. J. Pharm 2001;227:157165.
5. Bjorn, L. The clinical relevance of chronopharmacology in therapeutics. Pharmacol. Res
1996;33:10711.
9. NAME AND SIGNATURE OF THE
CANDIDTE
(ORCHU DURGABHAVANI)
NOT APPLICABLE
11.3 CO-GUIDE