CHAPTER-6 main functional groups wave numbers like –OH

CHAPTER-6

DISCUSSION
OF RESULTS

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6.1. Discussion on Calibration
Curve

The
following parameters were tabulated from calibration curve below.

Table 6.1: Factors
obtained from calibration curves of selected drugs

Drug

?
max (nm)

Correlation
coefficient (R2)

Inference

Simvastatin

238 nm

It
shows a good correlation and linearity within the concentration ranging from 3 to
18 µg/ml and shows r2  value as 0.998 in 7.4 pH buffer

Obeys
Beers law

Carvedilol

241 nm

It
shows a good correlation and linearity within the concentration ranging from 5 to
30 µg/ml and shows r2  value 0.998 in pH 7.4 buffer

The
results are shown in table
5.1-5.2 and figure 5.1-5.2 in chapter 5.

6.2 Preformulation
Studies

Based
on the results as shown in table
5.3 – 5.6 and figure 5.3 – 5.22,
the characterization of the drug and excipients are discussed as follows

Table 6.2: Solubility
studies of selected drugs

Parameter

Simvastatin

Carvedilol

Solubility

Low
soluble in water and highly soluble in lipid like witepsol, compritol
and stearic acid

Low
soluble in water and highly soluble in lipid like witepsol, compritol
and stearic acid

 

 

       

Table 6.3: Discussion
on drug and excipients compatibility studies by FTIR Studies

material

Discussion

Simvastatin and its
formulation NLC; NLC loaded Transdermal patch

The main
functional groups wave numbers like –OH stretching as 3551.55 cm-1, 2966.58 cm-1,
2872.80 cm-1, -C=o
stretching as 1723.73 cm-1,-C-O stretching as 1118.85 cm-1,
-C-H bending as 990.20 cm-1 in simvastatin drug; –OH stretching
as 3340 cm-1, 2944.50 cm-1, 2832.87
cm-1, -C-O stretching 1251.09 cm-1, 1081.79 cm-1 in Simvastatin NLC; –OH stretching as 3648.38
cm-1, 2922.12
cm-1, 2853.69 cm-1, -C=o stretching as 1732.87 cm-1, -C-H bending as
930.75 cm-1 in NLC loaded transdermal patch respectively.
Some of the functional groups is overlapped and absence, which may be due to
the complete encapsulation of lipid over Simvastatin.

Carvedilol and its
formulation NLC; NLC loaded Transdermal patch
 

The main
functional groups wave numbers like –OH stretching as 3337.85 cm-1, 2922.84 cm-1, -NH Stretching as 3337.85 cm-1, C-H Stretching as 1450.20 cm-1, -OH group as 1333.33 cm-1,
C-O Stretching as 1256.02 cm-1, -C-H bending as 851.29 cm-1
in Carvedilol drug; –OH stretching
as  3615.92 cm-1, 3394.03 cm-1,
 -N-H stretching 3350.52 cm-1, 1508.99 cm-1 ,
-O-H group as 1342.64 cm-1 ,–C-o
stretching as 1239.05 cm-1,  -C-H bending as 842.38 cm-1 in Carvedilol NLC; –OH stretching as  3525.24 cm-1, 3448.30 cm-1,
-N-H stretching  1557.51 cm-1,   -O-H group as 1367.26 cm-1 ,–C-o stretching as 1180.16 cm-1,
 -C-H bending as 869.72 cm-1 in
NLC loaded transdermal patch respectively. Some of the functional
groups is overlapped and absence in Transdermal patches, which may be due to
the deep encapsulation of lipid over Carvedilol.

Inference

preferred functional group
frequencies are reproducible in NLC and transdermal
patch when compared to the standard drug. It was confirmed that the drugs and
excipients used in the formulation are good compatible to each other

 

Table
6.4: Discussion on crystal pattern studies of drug by DSC Studies

material

Discussion

Simvastatin and its
formulation NLC

The
following melting points are the observed as endothermic peak readings in DSC
thermograms as follows; Simvastatin 142.36 ° C; Lipid Compritol 888 ATO 76.60
° C; Simvastatin NLC thermogram shows two peaks i.e., primary peak at 75.00°C
(Lipid peak) and secondary peak at 126.40°C (Drug peak).

Carvedilol and its
formulation NLC

The
following melting points are the observed as endothermic peak readings in DSC
thermograms as follows; Carvedilol 118.02 °C; Lipid Compritol 888 ATO 76.60°C;
Carvedilol NLC thermogram shows two peaks i.e., primary peak at 74.50°C
(Lipid peak) and secondary peak (Drug peak) at 101.68°C.

Inference

While performing the DSC studies for NLC
formulation, lipid first melted followed by drug, which ensures drug was effectively
encapsulated within the lipid. This thermal behavior confirms the presence of
both the drugs in an amorphous form or molecularly dispersed in nature.

6.3. Discussion on Trial
Formulation

The results from table: 5.7-5.8 and figure: 5.23 show that all the NLC formulation
from F1- F9 attained nanosize range from 0.5 ± 0.02 to 15.3  ± 1.64 nm; better zeta potential as -11.4±
1.24 mV -39.4 ± 1.72 mV and PI in the range of 0.134  ± 0.022 to 0.187 ± 0.024. Among which F7 formulation
shows better particle size 10.7 nm, ZP -41.2 mV and Pi 0.187. And also F7 formulation showed maximum drug content
of about 85.80 ± 1.64 % and entrapment