FORMULATION AND EVALUATION OF ORODISPERSIBLE

FAST RELEASE FILM OF H1-ANTI HISTAMINE DRUG

DISSERTATION PROTOCOL

SUBMITTED TO THE

RAJIVGANDHIUNIVERSITY OF HEALTH SCIENCES

BANGALORE, KARNATAKA.

BY

MOHAMED IRSHAD PASHA

DEPARTMENT OF PHARMACEUTICS

M.M.U.COLLEGE OF PHARMACY

K.K DODDI,

RAMANAGARAM - 571511

UNDER THE GUIDENCE OF

Dr.THAHERA PARVEEN

PROFESSOR

DEPARTMENT OF PHARMACEUTICS

M.M.U.COLLEGE OF PHARMACY

RAMANAGARAM-571511

KARNATAKA

RAJIVGANDHIUNIVERSITY OF HEALTH SCIENCES

BANGALORE, KARNATAKA

ANNEXURE- II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1. / NAME OF THE CANDIDATE AND ADDRESS (IN BLOCK LETTERS) / MOHAMED IRSHAD PASHA,
1ST CROSS YARAB NAGAR MOHALLA,
RAMANAGARAM,
RAMANAGARA 571511.
2. / NAME OF THE INSTITUTION / M.M.UCOLLEGE OF PHARMACY
RAMANAGARAM-571511
3. / COURSE OF STUDY AND SUBJECT / M.PHARM,PHARMACEUTICS
4. / DATE OF ADMISSION OF COURSE / 02-06-2010
5. / TITLE OF TOPIC / FORMULATION AND EVALUATION OF ORODISPERSIBLE FAST RELEASE FILM OF H1-ANTI HISTAMINE DRUG
6. / BRIEF RESUME OF THE INTENDED WORK
6.1 Need For The Study
6.2 Review of the literature
6.3 Objective of the study / ENCLOSURE- I
ENCLOSURE-II
ENCLOSURE-III
7. / MATERIALS AND METHOD
7.1 Source of data
7.2 Method of collection of data
7.3 Does study require any
Investigations or interventions
To be conducted on patients or
Other human or animal? If so,
Please describe briefly,
7.4 Has ethical clearance been
Obtained from your institution in case of 7.3. / ENCLOSURE- IV
ENCLOSURE- V
ENCLOSURE-VI
ENCLOSURE-VII
8. / REFERANCE / ENCLOSURE-VIII
9. / SIGNATURE OF CANDIDATE
10. / REMARKS OF GUIDES / FORWARD FOR APPROVEL
11. / NAME AND DESIGNATION OF
11.1 GUIDE / Dr. THAHERA PARVEEN,
PROFESSOR,
DEPARTMENT OF PHARMACEUTICS,
M.M.U.COLLEGE OF PHARMACY,
RAMANAGARAM-571511.
11.2 SIGNATURE
11.3 CO GUIDE (IF ANY)
11.4 SIGNATURE
11.5 HEAD OF DEPARTMENT / Mr. VAZIR ASHFAQ AHMED,
ASST.PROFESSOR,
DEPARTMENT OF PHARMACEUTICS,
M.M.U.COLLEGE OF PHARMACY,
RAMANAGARAM-571511.
11.6 SIGNATURE
12. / 12.1 REMARKS OF THE
CHAIRMAN AND PRINCIPAL / SUBMITTED FOR APPROVAL
12.2 SIGNATURE
6 / BRIEF RESUME OF THE INTENDED WORK
ENCLOSURE- I
6.1 Need for the study
Fast-dissolving drug-delivery systems were first developed in the late 1970’s as an alternative to tablets, capsules, and syrups for pediatric and geriatric patients who face difficulties regarding oral dosage forms.
Fast-dissolving oral delivery systems are solid dosage forms, which are typically the size of a postage stamp, disintegrate or dissolve on a patients tongue within minutes or seconds when placed in the mouth without drinking water or chewing. Recently, fast-dissolving films are gaining interest as an alternative to fast-dissolving tablets to definitely eliminate patients fear of chocking and overcome patent impediments.
The films are flexible they are not as fragile and brittle as most of the oral dosage form. Hence, there is ease of transportation and during consumer handling and storage.Availability of larger surface area that leads to rapid dissolution in the oral cavity.
As compared to drops or syrup formulations, precision in the administered dose is ensured from each of the strips. Oral thin films offer fast, accurate dosing in a safe, efficacious format that is convenient and portable, without the need for water or measuring devices.
The oral films being highly vascularized, drugs can be absorbed directly and can enter the systemic circulation without undergoing first-pass hepatic metabolism. Since the first pass effect it can be avoided, there can be the reduction in the dose which can leads to reduction in side effects
.
ENCLOSURE- II
6.2 Review of the literature
  1. Basani Gavaskar, Subash Vijaya Kumar, Guru Sharan, Y.Madhusudan Rao,1prepared Oral dissolving film Technology (ODFTS) that can be administrated in the buccal cavity for a shorter period of time in Seconds and gives better therapeutic action. The methodologies used in the development of ODFTS for pediatric and geriatric patient’s population, who are difficulty in swallowing larger dosage forms. This technology has been used for local action, rapid release products. ODFT offers an alternate platform for molecules that undergoes first pass metabolism.
  1. Rakesh Patel, Naik Shardul, Jigar patel, Ashok Baria,2 Formulated, developed and evaluated Mouth Melting Film of an antiemetic drug Ondansetron. Low viscosity grade of hydroxy propyl methylcellulose (HPMC E 15) and Maltodextrin were used as excipient. due to their excellent film forming property and palatable taste. Glycerol and carragenan were used as a plasticizers and stabilizing agent, respectively. Increasing maltodextrin concentration in the formulation resulted in a brittle film formation as compared to lower concentration of the same. Higher concentration of HPMC E 15 was resulted in sticky film formation. Concentration of glycerol was optimized during preliminary studies.
  1. Soad A. Yehia, Omaima N. El-Gazayerly and Emad B. Basalious,3prepared Fluconazole mucoadhesive buccal films by using film forming polymers namely; hydroxypropyl methyl cellulose (HPMC), hydroxyethyl cellulose (HEC), chitosan, Eudragit and sodium alginate (SALG) either alone or in combination with bioadhesive polymers. The bioadhesive polymers studied were sodium carboxymethyl cellulose (SCMC), Carbopol 974P, and polycarbophil (AA-A)
  1. Kulkarni A.S., Deokule H.A., Mane M.S. and Ghadge D.M,4explored the different polymers for use in the formulation of fast dissolving strips.
  1. Mingj. Chen, gavin Watson, et al.,5prepared films benzocaine or caffeine were studied. Film Delivery Systems #1 and #2 were edible film sys-tems containing polymers, plasticizers, benzocaine or caffeine, sweeteners, flavors, colorants, and processing aids. System #3 was a buccal film deliv-ery system containing polymers, benzocaine, and colorants.
  1. Kok Khiang Peh, Choy Fun Wong,6investigated the suitability of an SCMC (sodium carboxy methyl cellulose/po lyethylene glycol 400/carbopol 934P) and an HPMC (hydroxypropylmethyl cellulose/polyethylene glycol 400/carbopol 934P) films as drug vehicle for buccal delivery.
  1. Joshi,7 administered to patients to treat xerostomia or dry mouth or sjogrens syndrom in the form of orally dissolving film or orally disintegrating tablets. Some of the drugs could be synthetic origin and some drugss are obtained natural sources.
  1. Francesco Cilurzo, Paola minghetti et al.,8evaluated the feasibility of a fast dissolving film made of a maltodextrin plasticized by glycerin by solvent free hot-melt extrusion technology. Loading capacity and the in vivo performances of the film were assayed by using paracetamol as model drug because its bioavailability can be determined in saliva.
  1. Aditya Dinge, Mangal Nagarsenker,9 Formulated and evaluated fast dissolving films for delivery of triclosan to the oral cavity. Various film forming agents, film modifiers and polyhydric alcohols were evaluated for optimizing the composition of fast dissolving films. Fast dissolving films containing hydroxypropyl methylcellulose (HPMC), xanthan gum, and xylitol were formulated.
  1. S. Kunte P. Tandale,10 investigated the possibility of developing verapamil (a calium channel blocker used as an anti angina, anti arrhythmic ,and anti hypertensive agent) fast dissolving films allowing fast reproducible drug dissolution in the oral cavity thus bypassing first pass metabolism.
  1. Mohammed Gulzar Ahmed, NM Harish, R Narayana Charyulu, Prabhakar Prabhu,11 designed to develop and evaluate chitosan films containing ciprofloxacin and diclofenac sodium for the topical treatment of periodontitis.
ENCLOSURE- III
6.3. OBJECTIVES OF THE STUDY :
  1. To select suitable polymers for orodispersible fast released films.
  2. To formulate orodispersible films containing Loratidine to ensure the fast release of the drug.
  3. To evaluate physicochemical properties for the prepared formulations.
  4. To carry out in vitro dissolution studies of orodispersible films.
ENCLOSURE- IV
MATERIALS AND METHOD
7. MATERIALS:
DRUG : NON SEDATIVE LONG ACTING ANTI HISTAMINE LORATIDINE.
POLYMERS :The polymer may include cellulose or a cellulose derivative.water soluble polymers include, hydroxypropylmethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, polyvinyl pyrrolidone, carboxymethyl cellulose, polyvinyl alcohol, sodium aginate, polyethylene glycol, xanthan gum, etc.
PLASTICIZERS: Plasticizers include glycerin, sorbitol, propylene glycol, polyethylene glycol, triacetin, triethyl citrate (TEC), acetyl triethyl citrate (ATEC) and other citrate esters.
FLAVOURING AGENT:Strawberry
SWEETNING AGENTS: Sugar, dextrose, lactose, mannitol, sucrose, aspartame, saccharin
CLOURING AGENT: Red or Yellow FD&Capproved.
METHODS OF MANUFACTURE OF FILMS:
  • Solvent casting
  • Hot-melt extrusion
  • Solid dispersion extrusion
7.1.SOURCE OF THE DATA:
1)Review of literature from:
  1. Journals: such as . -International journal of pharmaceutical
-Biomaterials.
. -Pharmaceutical research.
-European journal of pharmaceutical sciences.
-Drug development and industrial pharmacy.
  1. Internet browsing.
2)Laboratory based studies
3)Library: M.M.U. college of pharmacy
4)Digital library Of RHUHS ( Helinet )
ENCLOSURE- V
7.2. Method of collection of data:
The steps that will be followed are:
  1. Preparation of mouth dissolving films of loratidine
  2. Pre and Post formulating studies.
  3. Oro Films evaluated for:
It vitro dissolution studies.
Stability studies.
Solubility studies by using different solvent.
Folding endurance, flexibility, tensile strength, thickness uniformity of drug contents.
ENCLOSURE- VI
7.3 Does the study require any investigation or intervention to be conducted on patients or other? Humans or animals? If so, please mention briefly.
Not applicable.
ENCLOSURE- VII
7.4. Has ethical clearance been obtained from your institution in case of 7.3?
Not applicable.
ENCLOSURE- VIII
LIST OF REFERANCE:
  1. Basani Gavaskar, Subash Vijaya Kumar, Guru Sharan, Y.Madhusudan Rao, “Over view On fas dissolving films” International Journal of Pharmacy and Pharmaceutical Sciences, Vol 2, Suppl 3, 2010.
  2. Rakesh Patel, Naik Shardul, Jigar patel, Ashok Baria, “Formulation Development and Evaluation of Mouth Melting Film of Ondansetron”, Arch Pharm Sci & Res Vol No. 1, 212-217, 2009.
  3. Soad A. Yehia, Omaima N. El-gazayerly and emad B. Basalious“Fluconazole mucoadhesive buccal films in vitro/in vivo performance” Current drug delivery, Vol No 6, 17-27, 2009.
  4. Kulkarni A. S., deokule H.A., Mane M.S. And Ghadge D. M. “Exploration of different polymers for use in the formulation of oral fast dissolving strips” Journal of current pharmaceutical research vol no. 2(1), 33-35,2010.
  5. Ming J. Chen, Gavin Watson, et al., “Castable edible pharmaceutical films” Poster presented at the 2007 annual meeting and exposition of the american association of pharmaceutical scientists san diego, california November -15-2007.
  6. Kok Khiang Peh, Choy Fun Wong“Polymeric films as vehicle for buccal delivery: swelling, mechanical, and bioadhesive properties.”J pharm pharmaceut sci () vol No. 2 (2),53-61,1999.
  7. Hemant N. Joshi “Unied states, patent application publication” Pub.no.us 2009/0263467 a1, pub. Date oct.22,2009.
  8. Francesco Cilurzo1,2, paola “Maltodextrin fasmaltodextrin fast-dissolving film: A feasibility study”
  9. Aditya Dinge and Mangal Nagarsenker “Formulation and evaluation of fast dissolving films for delivery of triclosan to the oral cavity” Aaps pharmscitech, vol No 9(2),349-356, Feb 2008.
  10. S.kunte, P. Tandale “Fast dissolving strips: a novel approach for the delivery of verapamil” Journal of Pharmacy and bioallied sciences Vol No. 2 Issu 4, 325-328, December 2010.
  11. Mohammed Gulzar Ahmed, NM Harish, R Narayana Charyulu, Prabhakar Prabhu “Formulation of chitosan-based ciprofloxacin and diclofenac film for periodontitis therapy”Tropical journal of pharmaceutical research,Vol No. 8 (1), 33-4, Feb 2009.