Research Journal of Pharmaceutical Dosage Form and Technology

B. Soujanya ¹, G. Pavani Priya ¹, T. E. G. K. Murthy ²

Affiliations
1 Department of Pharmaceutics, Bapatla College of Pharmacy, Bapatla-522101, Guntur, Andhra Pradesh, IN
2 Bapatla College of Pharmacy, Bapatla-522101, Guntur, Andhra Pradesh, IN

Abstract

The objective of the present study is to formulate and evaluate delayed release pellets of Omeprazole and to protect the drug from gastric fluids. The pellets were processed by employing FBC. The drug and excipient interaction studies were conducted with IR spectral studies and drug and the selected excipient were found to be compatible. Various process variables such as inlet air temperature, pump RPM, atomization air pressure, %damper opening, spray rate and formulation variables such as the concentration of alkalizing agent CaCo3, surfactant SLS and binder PVP in drug loading, the concentration of sub coating material HPMCE5 in barrier coating and the enteric coating material eudragitL30D55,the plasticizer PEG6000 were studied. The parameters such as exhaust air temperature, product temperature, physical appearance, size and size distribution, drug content, friability, acid resistance, moisture content and drug release were monitored during the study. Processing was found to be better when the inlet air temperature (50-600c), spray rate (1-6rpm), %damper opening (6.5-7) and atomized air pressure (1.8 kgcm2) were maintained. The optimized concentrations of CaCo3, SLS and PVP were found to be 0.235%, 0.033%, 0.019% respectively for drug loading.0.947%w/w HPMCE5 was found to be suitable for barrier coating and0.0874%w/w eudragitL30D55, 0.0322%PEG6000, 0.0051% NaOH was found to be optimum for enteric coating. The finished dosage form was subjected to short term stability studies as for ICH guidelines and optimized formulation was found to be quite stable.

Keywords

Omeprazole, Enteric Coating Polymer EudragitL30 D55, Sub Coating Polymer HPMCE5 Acid Resistance.

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B. Soujanya ¹, G. Pavani Priya ¹, T. E. G. K. Murthy ²

Affiliations
1 Department of Pharmaceutics, Bapatla College of Pharmacy, Bapatla-522101, Guntur, Andhra Pradesh, IN
2 Bapatla College of Pharmacy, Bapatla-522101, Guntur, Andhra Pradesh, IN

Abstract

Co-processed excipients with microcrystalline cellulose and guar gum, xanthan gum, almond gum, kondagogu in different ratios were fabricated by different methods and its influence on blend fluidity, friability of the tablet and dissolution characteristics of diclofenac sodium from direct compressible tablets was studied. The flow properties of the blends were determined by Carr's index and Hausner's ratio. Optimized co-processed formulation containing microcrystalline cellulose and guar gum in the ratio 1:3 was found to be more acceptable to formulate diclofenac sodium tablets. The co-processed excipients were prepared by using granulation technique. The preformulation parameters like flow property and the performance parameters were dependent on the proportion of components present in the co-processing excipient. The co-processed excipient prepared with granulation technique imparted the desired qualities to the tablet. The drug dissolution rate followed zero order kinetics. The mechanism of drug release was governed by peppas model. The dissolution exponent of release profiles(slope) has a value of 0.59-1.05(n>1), which indicates super case ц transport diffusion. The drug and excipient interaction studies were conducted with IR spectral studies and drug and the selected excipient were found to be compatible. The finished dosage form was subjected to short term stability studies as for ICH guidelines and optimized formulation was found to be quite stable. The results obtained in the present study thus indicate that the gums and its concentrations used in the preparation of tablets have shown significant influence on drug release rate.

Keywords

Diclofenac Sodium, Co-Processed Excipients, Guar Gum, Xanthan Gum, Almond Gum, Kondagogu.

Full Text

     

B. Soujanya ¹, G. Pavani Priya ², T. E. G. K. Murthy ¹

Affiliations
1 Bapatla College of Pharmacy, Bapatla-522101, Guntur, Andhra Pradesh, IN
2 Department of Pharmaceutics, Bapatla College of Pharmacy, Bapatla-522101, Guntur, Andhra Pradesh, IN

Abstract

Tablet manufacturing has been changed by the introduction of the direct‐compression process and high‐speed machines. These two developments have increased the demands on the functionality of excipients in terms of flow and compression properties. Direct compression is the preferred method for the preparation of tablets. The co-processing is the most widely explored method for the preparation of directly compressible adjuvants because it is cost effective and can be prepared in‐house based on the functionality required. This review article is in pursuit of giving detailed information on the sources of new excipients, potential advantages of co-processed excipients, material characteristics required for co-processing, methods of preparing directly compressible adjuvants and various co-processed excipients for direct compression available in the market.

Keywords

Direct Compression, Co-Processed Excipients, Co-Processing, Directly Compressible Adjuvants, Particle Engineering.

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