Gaurav V. Trivedi department of pharmaceutics under the guidance of



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PREPARATION AND EVALUATION OF MUCOADHESIVE BUCCAL SUSTAINED RELEASE DOSAGE FORM OF NSAIDS WITH HYDROTALCITE.

DISSERTATION PROTOCOL


SUBMITTED TO THE
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCE

BANGLORE, KARNATAKA.

BY
GAURAV V. TRIVEDI

DEPARTMENT OF PHARMACEUTICS

UNDER THE GUIDANCE OF
MR. VAZIR ASHFAQ AHMED

ASST. PROFESSOR

DEPARTMENT OF PHARMACEUTICS

M.M.U COLLEGE OF PHARMACY

RAMNAGARAM-571511.

KARNATAKA

RAJIVGANDHI UNIVERSITY OF HEALTH SCIENCES

KARNATAKA,BANGLORE.


Annexure-I

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSRTATION

1

NAME OF THE CANDIDATE AND ADDRESS(IN BLOCK LETTERS)

GAURAV V. TRIVEDI

“SAVINAYA”

KAILASH NAGAR SOCIETY, 150”RINGROAD

RAJKOT-360005



2.

NAME OF THE INSTITUTION

M.M.U COLLEGE OF PHARMACY,

RAMNAGARAM-577511



3.

COURSE OF STUDY AND SUBJECT

MASTER OF PHARMACY IN PHARMACEUTICS.

4.

DATE OF ADMISSION OF COURSE

29-JUNE-2009

5.

TITLE OF TOPIC

PREPARATION AND EVALUATION OF MUCOADHESIVE BUCCAL SUSTAINED RELEASE DOSAGE FORM OF NSAIDS WITH HYDROTALCITE.

6.

BRIEF RESUME OF THE INTENDED WORK




6.1

NEED FOR THE STUDY

ENCLOSURE-I

6.2

REVIEW OF THE LITERATURE


ENCLOSURE-II

6.3

OBJECTIVE OF THE STUDY


ENCLOSURE-III

7.

MATERIALS AND METHODS




7.1

SOURCE OF DATA

ENCLOSURE-IV

7.2

METHOD OF COLLECTION OF DATA

ENCLOSURE-V

7.3

DOES STUDY REQUIRE ANY INVESTIGATION OR INVENTIONS TO CONDUCT ON PATIENTS OR OTHER HUMAN OR ANIMAL? IF SO,PLEASE DESCRIBE BRIEFLY.

ENCLOSURE-VI

7.4

HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTIUTION IN CASE OF 7.3

ENCLOSURE-VII

8.

REFERENCE

ENCLOSURE-8

9.

SIGNATURE OF CANDIDATE




10.

REMARKS OF GUIDE

FORWARDED FOR APPROVAL

11.

NAME AND DESIGNATION OF




11.1

GUIDE

MR. VAZIR ASHFAQ AHMED

ASST. PROFESSOR

DEPARTMENT OF PHARMACEUTICS,

M.M.U COLLEGE OF PHARMACY, RAMNAGARAM-571511,

KARNATAKA


11.2

SIGNATURE



11.3

CO GUIDE(IF ANY)




11.4

SIGNATURE




11.5

HEAD OF DEPARTMEMT

MR. VAZIR ASHFAQ AHMED

ASST. PROFESSOR,

DEPARTMENT OF PHARMACEUTICS,

M.M.U COLLEGE OF PHARMACY, RAMNAGARAM-571511,

KARNATAKA


12.

REMARKS OF THE CHAIRMAN AND PRINCIPAL

SUBMITTED FOR APPROVAL

12.1

SIGNATURE




6. BRIEF RESUME OF THE INTENDED WORK

ENCLOSURE-I
6.1. NEED FOR THE STUDY

Sustained release provides the most desirable dosing regimens with effective pharmacokinetic profile and pharmacodynamic response for drugs having less biological half life. Sustained release medication optimizes the delivery of medication in order to achieve a measurable control of therapeutic effect. It maximizes the bio-availability of the drug and provides better patient compliance with less side effects and prevent patient from multiple dosing.

The mucoadhesive formulation offers many advantages such as, reduction in daily dose administrations and is suitable for the treatment of irritation, pain, and discomfort associated with gingivitis, sore throats, laryngopharyngitis, cold, and periodontal surgery. Moreover, it adheres well to the gum and is simple to apply, which means that patient compliance is improved.

The nsaids in the oral cavity is restricted to very limited formulations such as mouthwash, sprays, gels, or lozenges, which cannot be used successfully since they do not adhere well and are washed away by saliva, and hence are quickly removed. But in the case of bilayered tablets, drug release can be rendered almost unidirectional; if the drug can be incorporated in the upper nonadhesive layer, its delivery occurs into the whole oral cavity.



The aim of this work is to design a sustained-release mucoadhesive bilayered tablet, using combination of mucoadhesive polymers and an inorganic matrix (hydrotalcite), for the administration of nsaids in the oral cavity.
Enclosure-II

Brief review of literature

1. Symptoms of nsaid-induced like non-specific colitis or exacerbating colonic diverticulitis or inflammatory bowel disease, and including abdominal pain, bloody diarrhoea and weight loss. Colonoscopy may show non-specific inflammation, ulceration or diaphragm-like stricture.1

2. A study was investigated on hydrotalcite to find out its intercalation with a nonsteroidal anti-inflammatory drug, and results, have shown that the release is in a controlled manner. Hydrotalcite is capable to intercalate diclofenac with a simple procedure and with a good drug loading capacity.2


3. The literature discussing about buccal mucosa as a route for sysmetic drug delivery, which offers several advantages for controlled drug delivery for extended periods of time. The area is well suited for a retentive device and appears to be acceptable to the patient. Buccal drug delivery is a promising area for continued research with the aim of systemic delivery of orally inefficient drugs as well as a feasible and attractive alternative for non-invasive delivery of potent peptide and protein drug molecules.3
4. A work was carried out to develop and optimized a bilayered muccoadhesive tablet which had an in vitro mucosal residence time of atleast 8 hours and in vitro release profile of both sustained release and immediate release as per pharmacokinetic requirements.4
5. The salt form of nimesulide may increase to flux across buccal membrane and salt was inserted into mucoadhesive tablet for buccal administration. Tablets were designed to prevent the loss of drug into the saliva by means of protective layer and placed on the area not in contact with the mucosa..5
6. This literature describes preparation of oraltablets of terbutaline sulphate using adhesive and mucoadhesive natural polymers. It was found that tablets prepared from natural mucoadhesive materials exhibit entended drug release property. The rate of drug release from the terbutaline matrix tablets depends on the ratio of mucoadhesive materials used. And drug release was found to be retarded.6
7. Mucoadhesive is a topic of current interest in the deign of drug delivery system. In recent years mucoadhesive drug delivery have been developed for oral,buccal,nasal routes. This article emphasis mainly on concepts of mechanism of action, factor affecting mucoadhesion, and its evaluation methods.7
8. Hydrotalcite-like compounds are layered solids having positively charged layers and interlayer charge-compensating anions. The hydrotalcite is biocompatible and has been used to intercalate a model drug, ibuprofen, in order to prepare a modified release formulation. The result of dissolution tests at ph 7.5 showed that the in vitro drug release was modified if compared with that obtained with comparative formulations. The mechanism of modified drug release has been interpreted on the basis of the ion exchange process of the ibuprofen anion intercalated in the lamellar host and phosphates contained in the intestinal fluid buffer..8
9. The intercalation reaction of diclofenac sodium (DFS) with layered inorganic compounds as examined on. The dissolution from tablet of DFS/gamma-TiP intercalation compound was examined by using a disintegrator. It was found that the dissolution rate appropriately controlled by mixing the disintegrator. The sent results suggested the different possibilities in the clinical field to use layered inorganic compounds such as drug delivery system (DDS)..9
10. A work was carried out to develop mucoadhesive tablets of omeprazole to avoid gastric degradation and first pass metabolism. Tablets were subjected to swelling study, surface pH, adhesive force and dissolution profile. 10

ENCLOSURE-III


OBJECTIVES OF THE STUDY



  1. To design a sustained release mucoadhesive bilayer tablets containing an NSAIDS with an antacid (hydrotalcite)

  2. The formulation is to be assessed for its antacid property.

  3. To design a formulation in a way like buccal route which is easy to mask the bitter taste of NSAIDS and to prepare a sustained dosage form.

  4. To study the invitro permeability studies.

  5. To optimize the formulation with different polymers and its ratio, mucoadhesive properties, and drug release profile from the dosage form.


7. MATERIAL AND METHODS:-

Materrial:-

Drug:- NSAIDS(Ibuprofen/Ketoprofen)
Mucoadhesive polymer:- Hydroxyl ethyl cellulose,

Hydroxy propyl methyl cellulose

Carbomer,carbopol
Inorganic matrix :- Hydrotalcite.
Other additives :- Starch, Talc. (if require only)
Method of preparation:-

Development of sustained release nsaids bilayer tablet using mucoadhesive polymer( first layer of tablet) and inorganic matrix i.e hydrotalcite and ibuprofen(second layer of tablet) by suitable production method using hydraulic-press.


ENCLOSURE-IV

    1. Sources Of Data:-

  1. Library: MMU college of pharmacy

  2. E-library (internet) : MMU college of pharmacy


ENCLOSURE-V

    1. Method of collection of data:-

Data on drugs, their property, sustained release dosage forms mucoadhesive studies, hydrotalcite, NSAIDS are to be collected through literature survey by reviewing several research articles and physiochemical databases. Extensive preformulation trials would provide in the selection of excepients and other ingradients. Such as below.



  1. Preformulation studies

      • Studies on physiochemical propeties of drug:-

Pharmaceutical evaluation:-

      • Bulk density

      • Tapped density

      • True density

      • Angle of repose

      • Hausner’s ratio

      • Carr’s index etc….

  1. Preparation of tablet:-

      • Dry granulation/ suitable other method.

      • Evaluation parameters:- Weight Variation, Hardness, Friability, Dissolution Parameters, SwellingIndex, Invitro permeability

Studies.


  1. Comparative dissolution studies of marketed formulation.



ENCLOSURE-VI


    1. . Does the study require any investigation or invention to be conducted on patients or other humans or animals? If so please mention briefly.

Not applicable



ENCLOSURE-VII


    1. Has ethical clearance been obtained from your institution in case of 7.3?

Not applicable


ENCLOSURE-VIII

  1. LIST OF REFERENCES:-



  1. Faucheron, Jean-Luc “Toxicity of non-steroidal anti-inflammatory drugs in the large bowel” Eur J Gastroenterol Hepatol 11:389-392 1999 Lippincott Williams & Wilkins 11 (4)




  1. Ambrogi VFardella GIntercalation compounds of hydrotalcite-like anionic clays with anti-inflammatory agents, II: Uptake of diclofenac for a controlled release formulation PMID: 12916941 [PubMed - indexed for MEDLINE]




  1. Amir H. Shojaei, Edmonton, “Buccal Mucosa As A Route For Systemic Drug Delivery”: A Review3 J. Pharm. Pharma. Sci (www.ualberta.ca/~csps) 1 (1):15-30, 1998




  1. Pallavsangani, G SivakumarreddyFormulation and development of a bilayer mucoadhesive tablet containing ambroxol and salbutamol61st Indian pharmaceutical congress journal, poster no. A-248.




  1. P. Maffei, S.Lombardi Borgia “Mucoadhesive tablets for buccal administration containing Sodium Nimesulide” Drug Delivery Journal 2004, 11(4), 225-230.




  1. Chanda R, Nath L.K, Mahapatra S.Design and evaluation of mucoadhesive controlled release oral tablets of terbutaline sulphate using some natural mucoadhesive materials.”- Ind drugs- September-2008 ,45(9),743-746




  1. Asane G.S, Rao Y.M “Mucoadhesive gastrointestinal drug delivery system:An overview.”- Ind drugs- August-2007,44(8) ,577-584




  1. Grandolini GPerioli L. “Intercalation compounds of hydrotalcite-like anionic clays with antiinflammatory agents--I. Intercalation and in vitro release of ibuprofen.” 2001 Jun 4;220(1-2):23-32. PMID: 11376964 [PubMed - indexed for MEDLINE]




  1. Tajima TSuzuki N, “Intercalation compound of diclofenac sodium with layered inorganic compounds as a new drug material.” Nov;53(11):1396-401 PMID: 16272720 [PubMed - indexed for MEDLINE]




  1. Mahale G.H., Kothawade P.I. “Formulation and evaluation of buccoadhesive bilayer tablets of omeprazole” 61st Indian pharmaceutical congress journal poster no.- A-246




  1. Shaila Lewis, G SubramanianDesign, evaluation and pharmacokinetic study of mucoadhesive buccal tablets of nicotine for smoking cessation.” – Ind J.Pharma. sci 2006,68(6) 829-831.

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