ABOUT AUTHORS: *S. Patel, M. Patel
Department of Pharma. Technology,
L.J.Institute of Pharmacy, Ahmedabad, Gujarat, India shivanipatel090390@gmail.com
ABSTRACT:
The present research concerns the formulation and evaluation of sustained release pellets filled capsule of opioid analgesic, Tramadol HCl. Developmentof sustained release dosage form is to maintain therapeutic blood levels of the drug for extended period of time. Sustained release formulation provides uniform concentration at absorption site, maintains plasma concentration within a therapeutic range, reduces the dosage frequency and minimizes the side effects (nausea) associated with drug by avoiding dose dumping effect. Oral sustained release pellet formulations of Tramadol HCl were prepared using extrusion-spheronization technique. Pellets provide specific advantages of smoother plasma concentration profile and gradual absorption than tablet. Various polymers like Hydroxy propyl methyl cellulose (HPMC K100M), Carbopol, Xanthan gum, Ethyl cellulose and Eudragit RSPO were used to screen the best polymer combination through preliminary formulations. HPMC K100M and EC were screened and their concentrations were optimized using 32 full factorial design to achieve the aim of sustaining the drug release for 12 hours. Eudragit RSPO was used to coat the pellets. The prepared pellets were studied for different flow properties and drug release studies.
ABOUT AUTHORS: Soma Vinisha*, Sajida Akhtari Begum, Nikhat Tabassum, Soma Anusha
Department of pharmaceutical science,
Bharat Institution of Techology, Hyderabad, India choti.reddy@gmail.com
ABSTRACT
Purpose: This study aimed to formulate Ambroxol hydrochloride SR matrix tablets using xanthan gum (natural polymer) and to elucidate the release kinetics of Ambroxol hydrochloride from xanthan gum-matrices. Methods: controlled release matrix tablets of ambroxol hydrochloride, a mucolytic expectorant were prepared by wet granulation method using xanthan gum as natural hydrophilic polymer in three different ratios (Drug : Polymer 1:1(F-1), 1:1.5(F-2), 1:2(F-3)). The prepared granules of three different formulations were evaluated for angle of repose, bulk density (BD), tapped density (TD) and compressibility index (CI), hausners ratio. The prepared tablets were tested for physical parameters like weight variation, hardness, friability, content of active ingredient and In-vitro drug release studies. Results: The results obtained were within the prescribed limits. The release of ambroxol from the matrix tablets was sustained up to 12hrs. The cumulative percentage of drug release was decrease with increase in polymer concentration. Among the three formulations F-3 gave the release profile close to the commercially available marketed sample of ambroxol Hcl (A-MS).The results indicate that the drug release from the matrix tablets followed Zero order kinetics. The dissolution data was fitted to Korsmeyer equation which is used to describe the drug release behaviour from polymeric systems. All the formulations showed diffusion co-efficient value (n) greater than 0.43 but less than 0.85 after fitting to the Korsmeyer equation. So, it indicates Non-Fickian transport mechanism. Therefore the drug release is by diffusion and erosion mechanism. Conclusion: Matrix tablets of Ambroxol Hydrochloride using xanthan gum prepared by wet granulation method were found to be good in appearance. The drug-polymer ratio was found to influence the release of drug from the formulations. Formulation F-3 i.e. (1:2 drug: polymer) exhibited the similar In-vitro drug release rates as that of the marketed sample.