FORMULATION OF DOXYCYCLINE LOADED FLOATING FILM USING BIO-MATERIAL EXTRACTED FROM TAGETES erecta

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About Authors:
Prof. (Dr.) N.V.Satheesh madhav, Rohit Singh Negi, *Vikash kumar
DIT-Faculty of Pharmacy,
Dehradun Institute of Technology,
Mussoorie Diversion Road,
Makkawala, P.O. Bhagwantpur,
Dehradun, Uttrakhand
*vikashmalik81@gmail.com, satheesh_madhav@yahoo.com

Abstract:
The aim of research work was to isolate novel biopolymer from the seeds of Tagetes erecta and to characterize its physicochemical properties along with the acute toxicity. The isolated polymer was subjected for screening its retard ability by using as a bio nano carrier for formulating Doxycycline (model drug) loaded floating films. Tagetes is a genus of 56 species of annual and perennial mostly herbaceous plants in the sunflower family. The genus is native to North and South America, but some species have become naturalized around the world. Tagetes species vary in size from 0.01 to 2.2m tall. They have pinnate green leaves blooms are naturally in golden, orange, yellow and white colors, often with maroon highlights. Tagetes grow well in almost any sort of soil. It contains essentials oils, fatty acids, carotenoids and lutein. Tagetes erecta has long been known for its medicinal use, especially for strengthening the heart, and for treating ailments like headaches, swellings and tooth aches.  Tagetes erecta seeds were soaked in water and then washed with chloroform and ethyl acetate. Obtained 100 gm of fine powder was soaked in 100ml boiled water for 24 hours. The mixture was filtered and methanol was added in double. The solution was refrigerated for 24 hours and then centrifuged. Precipitate was collected as biopolymer and was dried. The separated biopolymer was subjected for various physicochemical parameters like color, texture, particle size, solubility, colour changing point. Spectral analysis such as IRspectroscopy was done to check the polymeric nature of biopolymers. Drug–polymer interaction and skin irritancy studies are also done to check the polymer safety.

REFERENCE ID: PHARMATUTOR-ART-2067

PharmaTutor (ISSN: 2347 - 7881)

Volume 1, Issue 2

Received On: 26/11/2013; Accepted On: 03/12/2013; Published On: 20/12/2013

How to cite this article: Kumar V, Madhav NVS, Negi RS, Formulation of Doxycycline Loaded Floating Film using Bio-Material Extracted from Tagetes Eracta, PharmaTutor, 2013, 1(2), 106-128

Doxycycline loaded floating films was formulated using biopolymer Tagetes erecta such as (FT 1 to FT 9) in differentratio (1:2 to 1:18). Then these floating films were subjected for various evaluation parameters as weight uniformity, surface pH, thickness, folding endurance, content uniformity, floating cum mucoadhesive study, in-vitro and ex-vivo drug release and in-vivo bioavailability and stability study. Based on comparison study of t50 and t80 FT4 were considered as the best formulation.

Conclusion was drawn that isolated material from the seeds of Tagetes erecta was devoid of acute toxicity and shows polymeric nature which was conform by spectral studies. Apart from that biopolymer it also inbuilt retardability which was confirmed by formulating floating film.

Introduction
Floating systems or dynamically controlled systems are low-density systems that have sufficiently buoyancy to float over the gastric contents and remain buoyant in the stomach without affecting the gastric emptying rate for a prolonged period of time. This results in an increased gastric retention time and a better control of the fluctuations in plasma drug concentration. Many buoyant systems have been developed based on granules, powders, capsules, tablets, laminated films and hallow Microspheres[1][2].

Gastroretentive drug delivery is an approach to prolong gastric residence time, thereby targeting site-specific drug release in the upper gastrointestinal tract (GIT) for local or systemic effects. Gastroretentive dosage forms can remain in the gastric region for long periods and hence significantly prolong the gastric retention time (GRT) of drugs. Over the last few decades, several gastroretentive drug delivery approaches being designed and developed, including: high density (sinking) systems that is retained in the bottom of the stomach, low density (floating) systems that causes buoyancy in gastric fluid, mucoadhesive systems that causes bioadhesion to stomach mucosa, unfoldable, extendible, or swellable systems which limits emptying of the dosage forms through the pyloric sphincter of stomach, superporous hydrogel systems, magnetic systems etc. The current review deals with various gastroretentive approaches that have recently become leading methodologies in the field of site-specific orally administered controlled release drug delivery systems[3],[12].

The real challenge in the development of an oral controlled-release drug delivery system is not just to sustain the drug release but also to prolong the presence of the dosage form within the gastrointestinal tract (GIT) until all the drug is completely released at the desired period of time. Indeed, gastric drug retention has received significant interest in the past few decades. Most of the conventional oral delivery systems have shown some limitations related to fast gastric-emptying time[4].

This triggered the attention towards formulation of stomach specific (gastro retentive) dosage forms. This dosage forms will be very much useful to deliver ‘narrow absorption window drugs. Several approaches are currently utilized in the prolongation of the GRT, including floating drug delivery systems (FDDS), swelling and expanding systems, polymeric bioadhesive systems, high-density systems, modified-shape systems and other delayed gastric emptying devices[5].

NATURAL BIO-POLYMERS USED IN FLOATING DRUG DELIVERY SYSTEM:
The aim of this work is tried to give a brief overview to the role of natural bio-polymers in the development of floating drug delivery system. The use of bio-polymer is valuable based on biocompatibility and safety. Bio-polymers are generally employed in floating drug delivery system so as to target the delivery of drug to a specific region in the gastrointestinal tract i.e. stomach. Moreover, these bio-polymers are safe and nontoxic[6].

ADVANTAGES OF BIO-POLYMERS:
The various advantages[6] of natural plant based materials include.

·         Biocompatible and non-toxic;

·         Low cost;

·         Environmental-friendly processing;

·         Local availability;

·     They have better patient tolerance as well as public acceptance.

There is less chance of side and adverse effects with natural materials compared with synthetic one.

BASIC GIT PHYSIOLOGY
Anatomically the stomach is divided in to three regions Fundus, Body and Antrum (pylorus)[1]fig.2.The proximal part made of Fundus and body acts as a reservoir for undigested materials, whereas the antrum is the main site for mixing motions and acts as a pump for gastric emptying by propelling actions. Gastric emptying occurs in both the fasting and fed states. During the fasting state an interdigestive series of electrical events take place which cycle both through stomach and intestine every 2-3 hrs, which is called as interdigestive myloelectric cycle or migrating myloelectric cycle (MMC) which is further divided in to four phases After the ingestion of a mixed meal, the pattern of contractions changes from fasted to that of fed state which is also termed as digestive motility pattern[7].

1. Phase 1-(Basic phase)-last from 30-60 minutes with rare contractions.

2. Phase 2-(Preburst phase)-last for 20-40 minutes with intermittent action potential and contractions.

3. Phase 3-(Burst phase) - last for 10-20 minutes which includes intense and regular contractions for short period.

4. Phase 4-last for 0-5 minutes and occurs between phase 2 and 1 of 2 consecutive cycles (Fig1).

After the ingestion of a mixed meal, the pattern of con-tractions changes from fasted to that of fed state which is also termed as digestive motility pattern.

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