Odourless Powder Essay

8. RESULTS AND DISCUSSION

8.1 PREFORMULATION STUDIES
8.1.1 Characterization of Oxubutynin chloride
8.1.1.1 Organoleptic properties
The sample of OXB was found to be a white crystalline practically odourless powder.
8.1.1.2 Melting point
Melting point of OXB was found to be in the range 124-129°C which is in range with the reported value (129°C).
8.1.1.3 Fourier transform infrared spectroscopic (FTIR) studies
The FTIR spectrum of OXB is shown in Figure 21 and interpretation of FTIR spectra is given in Table 21.

Figure 21: FTIR spectrum of pure OXB

Table 21: Interpretation of FTIR spectrum of pure OXB
Characteristic Peak (cm-1) Frequency (cm-1)
OH stretching 3500.92
OH Bending 1084.03
C-H stretching 3095.95
C-N stretching 1105.95
C=O

Table 24: Micromeritic characterization of OXB
Sr. No. Parameters Result
1 Loose bulk density 0.28±0.03g/cm3
2 Tapped density 0.46±0.06g/cm3
3 Carr’s Index 37.44±0.03 %
4 Hausner’s ratio 1.59
5 Angle of Repose 26º 34’
From the above results it is evident that OXB exhibits poor flow properties.

8.1.2 Determination of solubility
The solubility data for OXB as observed in 0.1 N HCl, pH 4.5 Acetate buffer, pH 6.8 Phosphate buffer and Purified water is presented in Table 25.
OXB exhibited a pH independent solubility phenomenon in all pH conditions and various aqueous buffers.
Table 25: Solubility data of OXB
BCS solubility (pH solubility) profile of OXB
Sr. No Media mg / ml
1 0.1 N HCl 249.119
2 pH 4.5 Acetate buffer 258.623
3 pH 6.8 Phosphate buffer 260.877
4 Purified water 253.200 *Average of three determinants
8.1.3 UV-VIS spectrophotometric method for OXB
8.1.3.1 Selection of

MCC 101 Diluent
5. Mannitol Filler
6. Purified water Solvent
7. Aerosil Lubricant
8. Talc Glidant
9. Magnesium stearate Lubricant

8.3 Preparation of matrix tablets Seventeen different tablet formulations were prepared by using various polymers. First three formulations (F1A, F1B, F1C) were prepared by Wet granulation, Roll compaction and Direct compression methods respectively. The formula was same for all three batches. Among these methods direct compression method was selected for further trials as it was a smooth process compared to Wet granulation and Roll compaction and as well as it was observed that:
 Granules obtained from wet granulation were very hard and caused weight variation of compressed tablets due to varying size of granules during compression.
 Roll compacted blend showed problem during milling process and also showed flow variation due to rat holling in the hopper during compression.
8.4 Evaluation of powder blend
Blends were prepared by mixing all the excipients. The blends were evaluated for different parameters and it was observed that moisture content was NMT 3% for each blend, Carr's Index (%) was in the range of 13.44±0.02 to 16.20±0.03, Hausner's