SHRINIVAS GUJRAT LABORATORIES PVT. LTD.

“VEENA VIHAR” EKORATOLI 37 NO HIGHWAY, BINOIGUTIA

GAON P.O. DIKOM,DIST-DIBRUGARH ,ASSAM,786010.

BA/BE STUDY
(BIO-AVAILABILITY AND BIOEQUIVALENCE)

BIOWAIVER DOSSIRE

ANALYSED BY PREPARED BY CHECKED BY APPROVED BY

DESIGNATION (QC- Executive) (QA Executive) (QA-Manager) (QA-Head)
SIGNATURE
DATE

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 TABLE OF CONTENTS FOR BIOEQUIVALENCE STUDY
SR.NO GENERIC NAME CLAIM STRENGTH DOSAGE FORM PAGE-NO
1. Paracetamol I.P. 650 mg Tablet
2. Paracetamol I.P. 500 mg Tablet

3. Methyl Ergometrine I.P 0.125mg Tablet

Maleate

4. Ondansetron I.P 4 mg Tablet

5. Ferrous Ascorbate I.P. 100mg and Tablet

and folic acid 1.5 mg
6. Povidone Iodine I.P/U.S.P 5%W/W Ointment

7. Povidone Iodine 1.P. 5%W/V Liquid

8. Levocetirizine Di- I.P 2.5 MG Syrup

HCL

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 BACKGROUND AND METHODOLOGY FOR BIOEQUIVALENCE
STUDY:-

BA/BE Information are important in regulatory submissions.BA information

addresses the the absorption distribution and metabolism of an API while the BE
study establish the performance of the product intended for marketing by
comparing it with the bioavalability of the product already approved and
circulated in market.

This study provides reovides an assessment of bioequivalence study by the method

of “BIOWAIVER” in which a simple dissolution test is used as a surrogate for in-
vivo human studies for the assessment of bioequivalence studies.”BIOWAIVER”
is applied to a regulatory approval process when the application(Dossier) is
approved on the basis of evidence of equivalence other than the in-vivo BE-
Test.For solid oral dosage forms, the equivalence is determined on the basis of an
in vitro dissolution profile comparison between a multisource(Market brand) and
comparator product.

METHODOLOGY:-

DISSOLUTION PROFILE COMPARISON:-

In-vitro dissolution performance can be related to in- vivodrug performance such

as BA(bioavailibility).This comparison of dissolution profile is gaining importance
as a means of comparative BA-Study-That is BE(Bio equivalence study)

The mathematical approach is to determine the dissolution profile of the oral

solid dosage form at 50 rpm by paddle method in 900 ml medium at PH-1.2,4.5
and 6.8.If a dosage form is very rapisly dissolving i.e. 85% or more of the product
is dissolved in 15 minutes or less, a furher profile comparison is not necessary. If
other wise then the calculation of similarity factor f2 is done.In this study the
calculation of fit factor f2 was not required as the formulation of the API for both
market and our brand was found to be of the rapidly dissolving class.

REFERANCE OF STUDY:- United states pharmacopoeia(USP-37),The national

Formulary(NF-32), Volume 1-2, 2014.

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 1.PARACETAMOL 650 MG:-

CLASS:-Antipyretic.

BCS CLASS I –HIGH SOLUBILITY HIGH PERMIABILITY.

APPLICABLE FOR BIOWAIVER:-YES.

TABLE1.1:TABLE FOR COMPARISON OF DRUG RELEASE FOR BIOEQUIVALNCE

STUDY.

SR.NO PRODUCT TIME PH-1.2 PH-4.5 PH-6.8

NAME
1. SNGL BRAND 86.82% 88.52% 87.05%
15 MIN
2. PARAGE 650. 87.23% 87.47% 87.36%

INFERANCE:- Calculation of similarity factor f2 is not required as both the market and SNGL
brand are formulated as rapidly dissolving class.

TABLE:1.2 COMPARATIVE PROFILE FOR PARAGE 650 AND SNGL BRAND.

SR.NO PRODUCT COMPOSITION DISINTEGR DISSOLUTI ASSAY FRIABILITY WEIGHT
NAME ATION ON BY UV VARIATION
TIME (MIN) (PHOSPHAT
E BUFFER-
PH 5.8)TIME
30 MIN.

1 SNGL 02 MIN 20 98.69 % 100.22 0.52 % W/W 743.89 MG

BRAND PARACETAM SEC %
OL 650 MG W/W
(I.P.)
2 PARAGE 01 MIN 15 98.59 % 100.41 0.64 % W/W 741.42 MG
650 SEC %
W/W

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 2.PARACETAMOL 500 MG:-

CLASS:-Antipyretic.

BCS CLASS I –HIGH SOLUBILITY HIGH PERMIABILITY.

APPLICABLE FOR BIOWAIVER:-YES.

TABLE1.3:TABLE FOR COMPARISON OF DRUG RELEASE FOR BIOEQUIVALNCE

STUDY.
SR.NO PRODUCT TIME PH-1.2 PH-4.5 PH-6.8
NAME
1. SNGL BRAND 88.25% 86.69% 86.64%
15 MIN
2. PASAFE 500. 87.06% 86.65% 86.13%

INFERANCE:- Calculation of similarity factor f2 is not required as both the market and SNGL
brand are formulated as rapidly dissolving class.

TABLE:1.4 COMPARATIVE PROFILE FOR PARAGE 500 AND SNGL BRAND.

SR. PRODUCT COMPOSI DISINTEG DISSOLUTI ASSA FRIABILI WEIGHT
NO NAME TION RATION ON Y BY TY VARIATION
TIME (PHOSPHAT UV
(MIN) E BUFFER-
PH 5.8)

1 SNGL BRAND 09 MIN 02 96.97 % 100.73 0.62 % 610.00 MG

PARACET SEC % W/W
AMOL 500 W/W
MG
2 PARASAFE 10 MIN 54 96.87 % 100.17 0.56 % 611.15 MG
500 SEC % W/W
W/W

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 5.FERROUS ASCORBATE AND FOLIC ACID TABLETS(100 MG,1.5MG)

CLASS:-HEMATINIC.

TABLE:1.9 COMPARATIVE PROFILE FOR FARO XT TAB AND SNGL BRAND.

SR. PRO DISINTEGR DISSOLU ASSAY BY UV FRIABI WEIGHT
NO DUC ATION TION LITY VARIATION
T TIME (MIN) (PHOSPH FERRO FOLIC
NAM ATE US ACID
E BUFFER- ASCOR
PH 5.8) BATE
0.64 % 930.77 MG
1 SNGL 13 MIN 20 102.60 % 142.00 % W/W
BRA SEC W/W W/W
ND NOT
PRESENT
15 MIN 02 IN I.P 0.60 % 922.42 MG
2 FARR SEC 101.88 % 141.33 % W/W
O XT W/W W/W
TABL
ET

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6.FERROUS ASCORBATE AND FOLIC ACID SYRUP(30 MG,550 MCG):-

CLASS:-HEMATINIC.

TABLE:1.10 COMPARATIVE PROFILE FOR FARO XT TAB AND SNGL BRAND.

ASSAY BY UV
SL
N PRODUCT COMPOSI PH WEIGHT COMPOSITION
O NAME TION PER ML
FERROUS FOLIC ACID
ASCORBATE

1 SNGL BRAND FERROUS 5.23 1.13 102.37 % 155.64 % W/V

ASCORBA GM/ML W/V
TE &
FOLIC
2 FARO XT ACID 5.09 1.19 101.43 % 160.36 % W/V
SYRUP (I.P) GM/ML W/V

7.LEVOCETIRIZINE DI-HCL SYRUP 2.5MG:-

CLASS:-ANTIHISTAMINIC.

TABLE:1.11 COMPARATIVE PROFILE FOR HATRIC SYRUP AND SNGL BRAND.

SL
NO PRODUCT COMPOSITION PH WEIGHT PER ASSAY BY UV
NAME ML

1 SNGL BRAND 8.56 1.19 GM/ML 105.64 % W/V

LEVOCETIRIZIN
E SYRUP 2.5 MG
(I.P) 1.19 GM/ML
2 HATRIC 8.56 99.60 % W/V
SYRUP

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8. POVIDONE IODINE SOLUTION 5 % W/V

CLASS:-BACTERICIDIAL/ANTIBACTERIAL/ANTI-SEPTIC.

TABLE:1.12 COMPARATIVE PROFILE FOR INTADINE AND SNGL BRAND.

SL
NO PRODUCT NAME COMPOSITION PH ASSAY BY TITRATION.

1 SNGL BRAND 4.05 105.60 % W/V

POVIDONE IODINE
SOLUTION 5 % W/V
(I.P)
2 INTADINE 4.21 106.20 % W/V

9. POVIDONE IODINE OINTMENT 5 % W/W

CLASS:-BACTERICIDIAL/ANTIBACTERIAL/ANTI-SEPTIC.

TABLE:1.13COMPARATIVE PROFILE FOR CIPLADINE AND SNGL BRAND.

SR. NO
PRODUCT NAME COMPOSITION ASSAY BY UV

1 SNGL BRAND 104.28 % W/V

POVIDONE IODINE
5 % W/W
U.S.P
2 CIPLADINE 103.21 % W/V

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