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“FORMULATION AND IN-VITRO CHARACTERIZATION OF
FAST DISSOLVING TABLETS OF RANITIDINE HCL”
M. Pharm. Dissertation Protocol Submitted to
Rajiv Gandhi University of Health Sciences, Bangalore
Karnataka
By
Mr. KONAKONDLA NAGARAJU, B.Pharm.
Under the Guidance of
Mr. SHRINIVAS GOPAL HUKERI
Assistant Professor
DEPARTMENT OF PHARMACEUTICS
EAST WEST COLLEGE OF PHARMACY
BANGALORE – 560 091
2011 – 2013
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ANNEXURE II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1
Name of candidate and address KONAKONDLA NAGARAJU
(In Block Letters)
MAREMPALLI(VILLAGE),
KANEKAL(MANDAL),
ANANTAPUR(DIST)
ANDHRAPRADESH - 515871.
2
Name of the Institute
EAST WEST COLLEGE OF PHARMACY,
BANGALORE – 560 091.
3
Course of study and subject:
M.PHARM. PHARMACEUTICS.
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Date of admission of course:
29/10/2011
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Title of the topic:
“FORMULATION AND IN-VITRO CHARACTERIZATION OF FAST
DISSOLVING TABLETS OF RANITIDINE HCL”
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Brief Resume of this intended work:
6.1 Need for the study
6.2 Review of Literature
6.3 Objectives of study
Enclosure-I
Enclosure-II
Enclosure-III
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Materials and Methods:
7.1 Source of data
Enclosure-IV
7.2 Method of collection of data (Including sampling procedure, if any)
Enclosure-V
7.3 Does the study require any investigation or interventions to be conducted on
patients of humans or animals? If so, please describe briefly.
---------NO---------7.4 Has ethical clearance been obtained from your institution in case of 7.3?
-------NOT APPLICABLE-------
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List of References
Enclosure-VI
2
9
Signature of the candidate
Mr. KONAKONDLA NAGARAJU
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Remarks of the Guide
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Name and designation
(in block letters)
11.1 Guide
The proposed research work is recommended for
registration and approval
of Mr. SHRINIVAS GOPAL HUKERI
ASSISTANT.PROFESSOR
DEPT. OF PHARMACEUTICS
EAST WEST COLLEGE OF PHARMACY,
BANGALORE - 560091.
11.2 Signature
11.3 Co-Guide (if any)
------------
11.4 Signature
------------
11.5 Head of Department
Dr. VENKATARAJU. M.P.
PROFESSOR AND HOD
DEPT. OF PHARMACEUTICS
EAST WEST COLLEGE OF PHARMACY
BANGALORE-560091
11.6 Signature
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12.1 Remarks of the
Chairman /Principal
12.2 Signature
Prof. K. A. SRIDHAR
PRINCIPAL
EAST WEST COLLEGE OF PHARMACY,
BANGALORE.560 091.
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ENCLOSURE-I
6) Brief resume of the intended work:
6.1) Need for the study:
Oral dosage forms are popular, but for some it is difficult to swallow, for these reasons
formulation is modified into fast dissolving tablets as a novel drug delivery system. Fast
dissolving tablets are those when placed on the tongue disintegrates instantaneously
releasing the drug which dissolve or disperse within 15 sec to 3 minutes. Addition of
superdisintegrants is one of the popular techniques for the formulation of fast dissolving
tablets where by optimum concentration of superdisintegrants is added to the formulation
to achieve rapid disintegration1.
Peptic ulcer arises in the part of GIT which is exposed to gastric acid and pepsin. It is due
to imbalance between the aggressive factor (gastric acid, pepsin, helicobacter pylori) and
the defensive factor (gastric mucus, bicarbonate secretion, prostaglandins, nitric oxide
and innate resistance of the mucosal cells). In duodenal ulcer, acid secretion is high.
Ulceration is due to high concentration of gastric acid pepsin or due to infection of
helicobacter pylori2.
Ranitidine hydrochloride comes under furans. It is a non-imidazole blocker of those
histamine receptors that mediate gastric secretion (H2receptors).The Chemical name is:
dimethyl [(5-{[(2-{[(E)-1-(methyl amino)-2-nitroethenyl] amino} ethyl) sulfanyl]
methyl} furan-2-yl) methyl] amine HCL. Empirical formula is C13H22N4O3S∙HCL.
Average molecular weight is 314.404. Absorption of Ranitidine HCL is moderate it
undergoes hepatic metabolism and an H2 receptor antagonist, H2 antagonists are
competitive inhibitors of histamine at the parietal cell H2 receptor. They suppress the
normal secretion of acid by parietal cells and the meal-stimulated secretion of acid. They
accomplish this by two mechanisms: histamine released by ECL cells in the stomach is
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blocked from binding on parietal cell H2 receptors which stimulate acid secretion, and
other substances that promote acid secretion (such as gastrin and acetylcholine) have a
reduced effect on parietal cells when the H2 receptors are blocked. It is mainly used for
the treatment of peptic ulcer3.
The present aim is an attempt to formulate Ranitidine hydrochloride fast dissolving tablet
to increasing its disintegration rate, by using various techniques such as, direct
compression/wet granulation/ dry granulation/ intra and extra granulation technique or
any suitable method with suitable drug carriers. To evaluate the in-vitro drug release
studies.
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ENCLOSURE-II
6.2) Review of literature:
Chandira RM et al., have prepared fast dissolving tablets of Ondosetron hydrochloride
by direct compression method using different super disintegrates. All the formulations
were evaluated for disintegration time, wetting time, weight variation, percentage
friability and In-vitro dissolution rate. Formulations with 2% indion 414 and drug: Indion
204 in 1:2 ratio and with 2% indion 414 and drug: Eudragit E100 in 1:4 ratios showed the
disintegration time 10 seconds, 15 seconds and wetting time 30 seconds and 33 seconds
respectively. In-vitro dissolution studies of both formulations showed more than 90%
drug released within 15 minutes. In-vitro release profile, disintegration time and wetting
time remained unchanged after two months when stored at250C /60% RH and
at400C/75%RH4.
Prajapati BG et al., have investigated directly compressed orally disintegrating tablets of
Piroxicam for mechanical integrity, content uniformity and characterized different super
disintegrants were used in the formulation such as Crospovidone, Croscarmellose
sodium, Sodium starch glycolate’s by in-vitro disintegration time and in-vitro drug
release. The prepared tablets were evaluated for weight variation, thickness, hardness,
friability, drug content, disintegration time, wetting time and in-vitro drug release. The
orally disintegrating tablets of Piroxicam consisting of 7% Crospovidone showed the
minimum disintegration time, in comparison with other formulation, DSC studies
indicated compatibility between drug and excipients5.
Arya A et al., have prepared mouth dissolving tablets of Ranitidine hydrochloride using
sublimation method Ammonium bi carbonate as a sublimating agent. The tablets were
evaluated other formulation of mouth dissolving tablets of Ranitidine hydrochloride were
prepared by using Sodium starch glycolate and Croscarmellose sodium as super
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disintegrants. Tablets formulated by using Croscarmillose sodium as super disintegrant
showed better disintegrating property and drug release profile in comparison with other
formulated tablets prepared by sublimation method6.
Ahad HA et al., have made an attempt to develop mouth dissolving tablets of
Ondosetron hydrochloride by including Clove oil. The tablets were prepared by direct
compression technique, the formulated tablets were evaluated for preformulation, post
formulation parameters and result were found to be satisfactory. Formulated tablets with
Croscarmellose sodium as super disintegrant showed better drug release property and
drug content7.
Yadav IK et al., have formulated an uncoated micro pellet of Nimesulide to improve its
bio availability and micromeritic property and developed fast dissolving tablets, the
formulated Nimesulide micro pellets were used for development of fast dissolving
tablets. They evaluated for general characteristics and in-vitro dissolution. The
disintegration time and dissolution profile of fast dissolving tablets of Nimesulide micro
pellets were compared with the fast dissolving tablets containing plain Nimesulide and
formed that fast dissolving tablets prepared with Nimesulide micro pellets are fast
disintegrating and have improved dissolution profile then fast dissolving tablets prepared
with plain Nimesulide8.
Kakade SM et al., have designed Losartain potassium mouth dissolving tablets to
enhance the patient compliance and to provide a quick onset of action, mouth dissolving
tablets of Losartain potassium were formulated by direct compression method using super
disintegrant such as Poly Plasdone XL10 Croscarmellose sodium Explotab in different
concentration and evaluated for the pre compression parameters. The formulated tablets
were evaluated for post compression parameters and In-vitro dissolution profile.
Evaluated results showed that formulated tablets contain 5% w/w Plosidone XL10
released 99.26% in12 minutes9.
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Kawtikwar PS et al., have prepared bitter less fast dissolving tablets of Tizanidine
hydrochloride using Eudragit E100 as taste masking agent. Mass extrusion was the
technique used for prepared taste masked granules .the tablet was prepared with three
super disintegrants e.g. Sodium starch glycolate, Croscarmellose sodium and
Crospovidone. The blend was examined for pre compression parameters. The tablets
were evaluated for post compression parameters, the Disintegration time was 22 seconds.
Tablets prepared by using Sublimation method by using Camphor as sublimating agent. It
showed that tablets are prepared by addition of super disintegrant has less disintegration
time then those prepared by Sublimation method10.
Mehta M et al., have investigated the development of fast dissolving tablets of Sertraline
HCl. Different formulations were formulated by incorporating a combination of
superdisintegrants (physical mixtures and co-processed mixtures) Sodium starch
glycolate and Crospovidone by direct compression method. The formulations were
evaluated for various physicochemical parameters, disintegration time and in-vitro drug
release. The formulation had disintegration time less than 3 and released maximum
amount of drug by 5 minutes. Co-processed mixtures had less disintegration time as
compared to the physical mixtures11.
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ENCLOSURE-III
6.3) Objective of the study:
The present study is planned with the following objectives:

To bring out the fast dissolving tablets of Ranitidine hydrochloride.

Preparation and optimization of fast dissolving tablet containing Ranitidine
hydrochloride by, direct compression/ Wet granulation /Dry granulation /Intra and
Extra granulation technique by using different adjuvant’s and excepients.

To find out the compatibility between the drug and excepients.

To evaluate the pre compressional granular properties.

To investigate the post compressional parameters of prepared formulations.

To carry out in-vitro drug release studies for prepared formulation.
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ENCLOSURE- IV
7) Materials and Methods:
Materials:
Drug: Ranitidine hydrochloride.
Excepients: Micro crystalline cellulose, super disintegrants such as Croscarmellose
Sodium, crospovidone, sodium starch glycolate or any other suitable disintegrants will be
Selected alone or in combination for the development of fast dissolving tablets of
Ranitidine hydrochloride. Sweetening agent: Mannitol/Aspartame/sodium saccharin, or
any other suitable drug Carrier and excepients used to formulate FDT’s of Ranitidine
hydrochloride. And suitable polymer and excepients will be used in the formulation of
FDT’s.
Methods:
Preparation of fast dissolving tablets containing Ranitidine hydrochloride with different
super disintegrates will be prepared by wet granulation/ dry granulation/ direct
compression/ Intra and Extra granulation or any other suitable appropriate methods.
7.1) Source of data:
Data is collected from:

RGUHS library.

Internet.

Research and review publication.

International and Indian journals.
 Textbooks and reference books.
 Drug bank.
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ENCLOSURE-V
7.2) Method of collection of data:
 Standardization, selection, process development and preparation of fast dissolving
tablets containing Ranitidine hydrochloride.
 Evaluation of pre compression and post compression parameters for prepared
formulations
Pre compression parameters:

Angle of repose

Bulk density

Tapped density

Carr’s index

Compressibility index
Post compression parameters:

Weight variation

Hardness

Thickness

Friability

Water absorption ratio.

Wetting time.

In-vitro disintegration time.

In-vitro dissolution time.
 Estimation of drug content in the developed formulations.
 Investigation of in-vitro drug release profile for developed formulations.
 To carry out statistical analysis of in-vitro drug release for optimized formulated
tablets.
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ENCLOSURE- VI
8) List of references:
1. Bhowmik D, Chiranjib .B, Krishnakanth, Pankaj, Chandira R.M. Fast Dissolving
Tablet: An Overview. J Chem Pharm Res 2009:1(1):163-77.
2. Tripathi KD. Essentials of Medical Pharmacology 5thed. New Delhi (IND) Jaypee
Brother Medical Publication.2003:587-91.
3. www.drugbank.ca
4. Chandira RM, Bhowmik D, Venkaeteswarlu BS, Khumudhavalli MV and Dr. Jayakar
B. Formulation and evaluation of taste masked fast dissolving tablets of Ondosetron
hydrochloride. J pharm Res 2008:1(2):200-07.
5. Prajapati BG, Patel B. Formulation, evaluation and optimization of orally
disintegrating tablets of Piroxicam. Int J Pharm Tech Res 2010:3(2):1893-99.
6. Arya A, Sharma S, Jitendra Kumar, Chandra A, Jaiswal P. Formulation and
evaluation of mouth dissolving tablets of Ranitidine hydrochloride Int J Pharm Tech
Res 2010:2(2):1574-77.
7. Ahad HA, Anuradha CM, Suresh Kumar C, Reddy KKB and Jagadish Kumar D.
Novel approach in formulation and evaluation of mouth dissolving tablets of
Ondosetron hydrochloride. Int J App Bio Pharm Tech 2010:2(1):582-88.
8. Yadav IK, Jaiswal D, Singh HP, Chandra D and Jain DA. Formulation evaluation and
optimization of fast dissolving tablets containing Nimesulide micro pellets. Int J
Chem Tech Res 2009:1(4):910-14.
9. Kakade SM, Mannur VS, Ramani KB, Dhada AA, Navel CV and Bhagwat A.
Formulation and evaluation of mouth dissolving tablets of Losartan potassium by
direct compression technique. Int J Res Pharm Sci 2010:1(3):290-95.
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10. Kawtikwar PS, Zade PS and Sakarkar DM. Formulation, evaluation and optimization
of fast dissolving tablets containing Tizanidine hydrochloride. Int J Pharm Tech Res
2009:1(1):34-42.
11. Mehta M, Bhagwat DP, Gupta GD. Fast dissolving tablets of Sertraline
hydrochloride. Int J Chem Tech Res 2009:1(4):925-30.
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