PCP Disso v3

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Transcript of PCP Disso v3

PCP-Disso-v3Program developed by -Anant Ketkar, Vinay Patil and A.R. Paradkar,Dept. of Pharmaceutics,

Pune- 38, Maharashtra, India.

% Release (Average with Flux))Name of the Drug = NIMESULIDE Batch = FN1 Date = 12/4/05Loading Dose in mg = 100 100 100 Total no. of Readings, including 'Zero-time' reading = 11 Done by = mjuDiffusion Medium = Ph 1.2RPM = 100Volume of Dissolution Medium (ml) = 900Volume of Sample removed (ml) = 10Dilution Factor = 2Slope of Calibration curve = 17.4839Constant of Calibration curve = -0.1726R of Calibration curve = 0.9999

Skin/Membrane used = 0 0

RESULTSSr.No. Time Avg. %R SD Avg. Time Avg. Flux (mcg/cm^2/h)

1 0 0.000 0.00 0.00 0.002 1 23.436 0.01 0.50 #DIV/0!3 2 31.430 6.70 1.50 #DIV/0!4 3 37.985 5.45 2.50 #DIV/0!5 4 44.914 5.78 3.50 #DIV/0!6 5 51.229 5.24 4.50 #DIV/0!7 6 56.350 4.21 5.50 #DIV/0!8 7 61.950 4.62 6.50 #DIV/0!9 8 66.937 4.09 7.50 #DIV/0!

10 9 71.327 3.58 8.50 #DIV/0!11 10 74.530 2.55 9.50 #DIV/0!

Bharati Vidyapeeth Deemed University, Poona College of Pharmacy,

Area for diffusion studies (cm2) =

PCP Disso v3 Extra Tools >>>

Date 12/4/05Name of the Drug NIMESULIDE

Batch Code FN1Done by (Initials) mju

Unit used for calibration curve 1 ##11 ##

Dissolution Medium Ph 1.2RPM 100

Volume of Dissolution Medium 900 ## Loading dose in mg ##

10 ## Dose 1

2 ## Dose 2

No. of Replicates 3 Dose 3Time in

Slope 17.48393Constant -0.172581

Sr.No. Time Abs1 Abs2 Abs3 Abs4 Abs5 Abs61 0 0 0 0 0 0 02 1 0.7547 0.75465 0.75433 2 0.75455 1.1222 1.124154 3 1.0003 1.2947 1.29775 4 1.1975667 1.50625 1.509856 5 1.4045556 1.6823 1.68237 6 1.5897185 1.80625 1.80878 7 1.7348895 1.97275 1.973359 8 1.8936632 2.09955 2.1003

10 9 2.0311711 2.20635 2.207111 10 2.148207 2.26565 2.26485

Add values only in SKY BLUE coloured cells.It is a must to add the data in the fields marked with ##.

Total No. of Readings, including 'Zero-time' reading

Volume of Sample removed (if Fixed)

Dilution Factor (if Fixed)

(between 1 to 6) ##

Extra Tools >>>

Loading dose in mg ##

100 Dose 4

100 Dose 5

100 Dose 6

Calculator

Unit Convertor

PCP-Disso-v3Program developed by -Anant Ketkar, Vinay Patil and A.R. Paradkar,Dept. of Pharmaceutics,

Pune- 38, Maharashtra, India.

% Release (Average) with model fittingName of the Drug = NIMESULIDE Batch = FN1 Date = 12/4/05Loading Dose in mg = 100 100 100 Total no. of Readings, including 'Zero-time' reading = 11 Done by = mjuDissolution Medium = Ph 1.2RPM = 100Volume of Dissolution Medium (ml) = 900Volume of Sample removed (ml) = 10Dilution Factor = 2Slope of Calibration curve = 17.4839Constant of Calibration curve = -0.1726R of Calibration curve = 0.9999Model Fitting (Average)-

R kZero order 0.9002 8.6508 t-Table at P0.05 (Two Tails), DF=n-2:- 2.262T-test 6.203 (Passes)1st order 0.9892 -0.1407 Best fit model- MatrixT-test 20.285 (Passes)Matrix 0.9951 23.2542 Parameters for T-test 30.295 (Passes) Korsmeyer-Peppas Equation-Peppas 0.9893 22.3303 0.5211T-test 20.313 (Passes) 22.3303Hix.Crow. 0.9729 -0.0394T-test 12.629 (Passes)RESULTS Zero 1st order Matrix Peppas Hix.Crow.

Sr.No. Time Avg. %R SD 946 173 16 8 3281 0 0.000 0.00 0.000 0.000 0.000 - 0.0002 1 23.436 0.01 218.599 106.380 0.033 1.222 146.0883 2 31.430 6.70 199.622 47.727 2.120 0.379 92.6374 3 37.985 5.45 144.782 12.666 5.256 2.562 43.2895 4 44.914 5.78 106.322 3.549 2.541 1.153 22.3616 5 51.229 5.24 63.608 0.523 0.591 0.185 9.2827 6 56.350 4.21 19.765 0.422 0.373 0.209 0.8418 7 61.950 4.62 1.946 0.479 0.181 0.153 0.0019 8 66.937 4.09 5.150 0.370 1.354 0.885 0.817

10 9 71.327 3.58 42.643 0.227 2.446 1.329 3.04211 10 74.530 2.55 143.462 0.947 0.988 0.156 10.054

Bharati Vidyapeeth Deemed University, Poona College of Pharmacy,

n =k =

MODEL FITTING: Residual Sum of Squares

A22
Zero Order:- %Released = k.Time
A24
First Order:- log (Fraction unreleased) = (k/2.303).Time
A26
Matrix (Higuchi Matrix):- %Released = k.Time0.5
A28
Korsmeyer-Peppas Equation:- %Released = k.Timen OR log(%Released) = log(k) + n.log(Time)
A30
Hixson-Crowell Equation:- (Fraction unreleased)1/3 = 1- k.Time

0.9951

PCP-Disso-v3Program developed by -Anant Ketkar, Vinay Patil and A.R. Paradkar,Dept. of Pharmaceutics,

Pune- 38, Maharashtra, India.

% Release (Average) with model fitting, Q(t) and t(x%)Name of the Drug = NIMESULIDE Batch = FN1 Date = 12/4/05Loading Dose in mg = 100 100 100 Total no. of Readings, including 'Zero-time' reading = 11 Done by = mjuDissolution Medium = Ph 1.2RPM = 100Volume of Dissolution Medium (ml) = 900Volume of Sample removed (ml) = 10Dilution Factor = 2Slope of Calibration curve = 17.4839Constant of Calibration curve = -0.1726R of Calibration curve = 0.9999Model Fitting (Average)- Best fit model- Matrix

R k Parameters calculated by- Matrix modelZero order 0.9002 8.6508 Time Q (t) %Released t (x%)T-test 6.203 (Passes) hr hr

1st order 0.9892 -0.1407 T-test 20.285 (Passes) Matrix 0.9951 23.2542 T-test 30.295 (Passes) Peppas 0.9893 22.3303 T-test 20.313 (Passes) Parameters for Hix.Crow. 0.9729 -0.0394 Korsmeyer-Peppas Equation-T-test 12.629 (Passes) 0.5211t-Table at P0.05 (Two Tails), DF=n-2:- 2.262 22.3303

RESULTS Zero 1st order Matrix Peppas Hix.Crow.Sr.No. Time Avg. %R SD 946 173 16 8 328

1 0 0.000 0.00 0.000 0.000 0.000 - 0.0002 1 23.436 0.01 218.599 106.380 0.033 1.222 146.0883 2 31.430 6.70 199.622 47.727 2.120 0.379 92.6374 3 37.985 5.45 144.782 12.666 5.256 2.562 43.2895 4 44.914 5.78 106.322 3.549 2.541 1.153 22.3616 5 51.229 5.24 63.608 0.523 0.591 0.185 9.2827 6 56.350 4.21 19.765 0.422 0.373 0.209 0.8418 7 61.950 4.62 1.946 0.479 0.181 0.153 0.0019 8 66.937 4.09 5.150 0.370 1.354 0.885 0.817

10 9 71.327 3.58 42.643 0.227 2.446 1.329 3.04211 10 74.530 2.55 143.462 0.947 0.988 0.156 10.054

Bharati Vidyapeeth Deemed University, Poona College of Pharmacy,

n =k =

MODEL FITTING: Residual Sum of Squares

A22
Zero Order:- %Released = k.Time
A24
First Order:- log (Fraction unreleased) = (k/2.303).Time
A26
Matrix (Higuchi Matrix):- %Released = k.Time0.5
A28
Korsmeyer-Peppas Equation:- %Released = k.Timen OR log(%Released) = log(k) + n.log(Time)
A30
Hixson-Crowell Equation:- (Fraction unreleased)1/3 = 1- k.Time

PCP-Disso-v3Program developed by -Anant Ketkar, Vinay Patil and A.R. Paradkar,Dept. of Pharmaceutics,

Pune- 38, Maharashtra, India.

% Release (Average) with Q(t)Name of the Drug = NIMESULIDE Batch = FN1 Date = 12/4/05Loading Dose in mg = 100 100 100 Total no. of Readings, including 'Zero-time' reading = 11 Done by = mjuDissolution Medium = Ph 1.2RPM = 100Volume of Dissolution Medium (ml) = 900Volume of Sample removed (ml) = 10Dilution Factor = 2Slope of Calibration curve = 17.4839Constant of Calibration curve = -0.1726R of Calibration curve = 0.9999%Released at Time:-

Time Q (t)hr

RESULTSSr.No. Time Avg. %R SD SE-mean RSD

1 0 0.000 0.00 0.00 0.002 1 23.436 0.01 0.00 0.033 2 31.430 6.70 3.87 21.314 3 37.985 5.45 3.15 14.355 4 44.914 5.78 3.33 12.866 5 51.229 5.24 3.03 10.247 6 56.350 4.21 2.43 7.478 7 61.950 4.62 2.67 7.469 8 66.937 4.09 2.36 6.11

10 9 71.327 3.58 2.06 5.0111 10 74.530 2.55 1.47 3.42

Bharati Vidyapeeth Deemed University, Poona College of Pharmacy,

D29
Standard Deviation
E29
Standard Error of Mean
F29
Relative Standard Deviation

PCP-Disso-v3Program developed by -Anant Ketkar, Vinay Patil and A.R. Paradkar,Dept. of Pharmaceutics,

Pune- 38, Maharashtra, India.

% Release (Average)Name of the Drug = NIMESULIDE Batch = FN1 Date = 12/4/05Loading Dose in mg = 100 100 100 Total no. of Readings, including 'Zero-time' reading = 11 Done by = mjuDissolution Medium = Ph 1.2RPM = 100Volume of Dissolution Medium (ml) = 900Volume of Sample removed (ml) = 10Dilution Factor = 2Slope of Calibration curve = 17.4839Constant of Calibration curve = -0.1726R of Calibration curve = 0.9999

RESULTSSr.No. Time Avg. %R SD SE-mean RSD

1 0 0.000 0.00 0.00 0.002 1 23.436 0.01 0.00 0.033 2 31.430 6.70 3.87 21.314 3 37.985 5.45 3.15 14.355 4 44.914 5.78 3.33 12.866 5 51.229 5.24 3.03 10.247 6 56.350 4.21 2.43 7.478 7 61.950 4.62 2.67 7.469 8 66.937 4.09 2.36 6.11

10 9 71.327 3.58 2.06 5.0111 10 74.530 2.55 1.47 3.42

Bharati Vidyapeeth Deemed University, Poona College of Pharmacy,

D22
Standard Deviation
E22
Standard Error of Mean
F22
Relative Standard Deviation

PCP-Disso-v3Program developed by -Anant Ketkar, Vinay Patil and A.R. Paradkar,Dept. of Pharmaceutics,

Pune- 38, Maharashtra, India.

Name of the Drug = NIMESULIDE Batch = FN1 Date = 12/4/05Loading Dose in mg = 100 100 100 Total no. of Readings, including 'Zero-time' reading = 11 Done by = mjuDissolution Medium = Ph 1.2RPM = 100Volume of Dissolution Medium (ml) = 900Volume of Sample removed (ml) = 10Dilution Factor = 2Slope of Calibration curve = 17.4839Constant of Calibration curve = -0.1726R of Calibration curve = 0.9999

RESULTSSr.No. Time Avg. %R SD SE-mean Amt. (mg) % DE MDT RSD

1 0 0.000 0.00 0.00 0.00 0.00 0.00 0.002 1 23.436 0.01 0.00 23.44 11.72 0.50 0.033 2 31.430 6.70 3.87 31.43 19.58 0.75 21.314 3 37.985 5.45 3.15 37.98 24.62 1.06 14.355 4 44.914 5.78 3.33 44.91 28.83 1.43 12.866 5 51.229 5.24 3.03 51.23 32.68 1.81 10.247 6 56.350 4.21 2.43 56.35 36.19 2.15 7.478 7 61.950 4.62 2.67 61.95 39.47 2.54 7.469 8 66.937 4.09 2.36 66.94 42.60 2.91 6.11

10 9 71.327 3.58 2.06 71.33 45.54 3.25 5.0111 10 74.530 2.55 1.47 74.53 48.28 3.52 3.42

Bharati Vidyapeeth Deemed University, Poona College of Pharmacy,

% Release (Average with %Dissolution Efficiency & Mean Dissolution Time)

D22
Standard Deviation
E22
Standard Error of Mean
F22
Cumulative amount released (mg)
G22
% Dissolution Efficiency
H22
Mean Dissolution Time
I22
Relative Standard Deviation

PCP-Disso-v3Program developed by -Anant Ketkar, Vinay Patil and A.R. Paradkar,Dept. of Pharmaceutics,

Pune- 38, Maharashtra, India.

% Release (Average) & model fitting (with constraints) with Q(t) & t(x%)Name of the Drug = NIMESULIDE Batch = FN1 Date = 12/4/05Loading Dose in mg = 100 100 100 Total no. of Readings, including 'Zero-time' reading = 11 Done by = mjuDissolution Medium = Ph 1.2RPM = 100Volume of Dissolution Medium (ml) = 900Volume of Sample removed (ml) = 10Dilution Factor = 2 Constraints for model fittingSlope of Calibration curve = 17.4839 Lower (%R) = 0Constant of Calibration curve = -0.1726 Upper (%R) = 0R of Calibration curve = 0.9999Model Fitting (Average)- Best fit model- #DIV/0!

R k Parameters calculated by- 0Zero order #DIV/0! #DIV/0! Time Q (t) %Released t (x%)T-test #NUM! #NUM! hr hr

1st order #DIV/0! #DIV/0! T-test #NUM! #NUM! Matrix #DIV/0! #DIV/0! T-test #NUM! #NUM! Peppas #VALUE! #VALUE! T-test #NUM! #NUM! Parameters for Hix.Crow. #DIV/0! #DIV/0! Korsmeyer-Peppas Equation-T-test #NUM! #NUM! #VALUE!t-Table at P0.05 (Two Tails), DF=n-2:- 0 #VALUE!

RESULTS Zero 1st order Matrix Peppas Hix.Crow.Sr.No. Time Avg. %R SD #DIV/0! #DIV/0! #DIV/0! 0 #DIV/0!

1 0 0.000 0.00 #DIV/0! #DIV/0! #DIV/0! - #DIV/0!2 1 23.436 0.01 3 2 31.430 6.70 4 3 37.985 5.45 5 4 44.914 5.78 6 5 51.229 5.24 7 6 56.350 4.21 8 7 61.950 4.62 9 8 66.937 4.09

10 9 71.327 3.58 11 10 74.530 2.55

Bharati Vidyapeeth Deemed University, Poona College of Pharmacy,

n =k =

MODEL FITTING: Residual Sum of Squares

A22
Zero Order:- %Released = k.Time
A24
First Order:- log (Fraction unreleased) = (k/2.303).Time
A26
Matrix (Higuchi Matrix):- %Released = k.Time0.5
A28
Korsmeyer-Peppas Equation:- %Released = k.Timen OR log(%Released) = log(k) + n.log(Time)
A30
Hixson-Crowell Equation:- (Fraction unreleased)1/3 = 1- k.Time

PCP-Disso-v3Program developed by -Anant Ketkar, Vinay Patil and A.R. Paradkar,Dept. of Pharmaceutics,

Pune- 38, Maharashtra, India.

% Release (Average) & model fitting (with constraints)Name of the Drug = NIMESULIDE Batch = FN1 Date = 12/4/05Loading Dose in mg = 100 100 100 Total no. of Readings, including 'Zero-time' reading = 11 Done by = mjuDissolution Medium = Ph 1.2RPM = 100Volume of Dissolution Medium (ml) = 900Volume of Sample removed (ml) = 10Dilution Factor = 2Slope of Calibration curve = 17.4839Constant of Calibration curve = -0.1726R of Calibration curve = 0.9999Model Fitting (Average)-

R k Constraints for model fittingZero order #DIV/0! #DIV/0! Lower (%R) = 0T-test #NUM! #NUM! Upper (%R) = 01st order #DIV/0! #DIV/0!T-test #NUM! #NUM!

Matrix #DIV/0! #DIV/0! Best fit model- #DIV/0!T-test #NUM! #NUM!

Peppas #VALUE! #VALUE!T-test #NUM! #NUM! Parameters for Hix.Crow. #DIV/0! #DIV/0! Korsmeyer-Peppas Equation-T-test #NUM! #NUM! #VALUE!t-Table at P0.05 (Two Tails), DF=n-2:- 0 #VALUE!

RESULTS Zero 1st order Matrix Peppas Hix.Crow.Sr.No. Time Avg. %R SD #DIV/0! #DIV/0! #DIV/0! 0 #DIV/0!

1 0 0.000 0.00 #DIV/0! #DIV/0! #DIV/0! - #DIV/0!2 1 23.436 0.01 3 2 31.430 6.70 4 3 37.985 5.45 5 4 44.914 5.78 6 5 51.229 5.24 7 6 56.350 4.21 8 7 61.950 4.62 9 8 66.937 4.09

10 9 71.327 3.58 11 10 74.530 2.55

Bharati Vidyapeeth Deemed University, Poona College of Pharmacy,

n =k =

MODEL FITTING: Residual Sum of Squares

A22
Zero Order:- %Released = k.Time
A24
First Order:- log (Fraction unreleased) = (k/2.303).Time
A26
Matrix (Higuchi Matrix):- %Released = k.Time0.5
A28
Korsmeyer-Peppas Equation:- %Released = k.Timen OR log(%Released) = log(k) + n.log(Time)
A30
Hixson-Crowell Equation:- (Fraction unreleased)1/3 = 1- k.Time