Gastroretentive drug delivery system: An Overview
Muskan Rathor, Anshika Garg
Sanskar College of Pharmacy and Research, 201302, Ghaziabad, Uttar Pradesh, India.
*Corresponding Author E-mail: anshikacreations03@gmail.com
ABSTRACT:
Gastric emptying is a complex and incredibly factor process. This causes the unusualness of the bioavailability of medication delivery system. GRDDSs can improve the controlled delivery of medications that have an ingestion window by continuously delivering the medication for a delayed time before it arrives at its assimilation site. Gastro retentive drug delivery system (GRDDS)s have gotten huge consideration in the previous many years, because of the way that they can overcome the limitations of regular oral controlled released drug delivery system identified with quick gastric emptying time. An ideal GRDDS can be characterized as a system which stays in the stomach for an adequate time and deliver the active ingredients in a controlled way so that sustained action can be created. This, altogether broadens the duration of medication release, prolongs dosing interval and expands bioavailability of medications and consequently improves compliance of the patients and viability of pharmacotherapy. This article gives an outline of the fundamental ideas used to design drug dosage form with delayed gastric residence time as well as the factors influencing gastric emptying, favourable circumstances, deficiencies, formulation consideration and, elements that influence gastro retentive system. The principal emphasis is on the whole grouping and various types of GRDDSs.
KEYWORDS: GRDDS, Gastroretentive, Floating, Bioavailablity, Stomach.
INTRODUCTION:
Oral drug delivery system have ruled other drug delivery system for human administration because of their different preferences including ease of administration, adaptability in formulation, cost-adequacy, easy storage and transport, and high patient compliance. Oral drug delivery system face difficulties, for example, low bioavailability because of the heterogeneity of the gastrointestinal system, pH of the commensal flora, gastric retention time of the dosage form, surface region, and enzymatic action.
Regular medication delivery system may not conquer the issues forced by the gastrointestinal tract (GIT), for example, incomplete release of medications, decline in dose effectiveness, and frequent dose requirements.
Consequently, the 6 disappointment of traditional medication delivery system to hold drugs in the stomach may prompt the improvement of GRDDS. These system offer a few advantages, for example, improve gastro retentive time (GRT) of dosage form in the stomach as long as a few hours, expanded therapeutic adequacy of medications by improving medication retention, and reasonableness for targeted delivery in the stomach. Different medication conveyance frameworks (DDS) have been produced for maximising bioavailability, decreasing medication waste, extending therapeutic index and decreasing the symptoms of the medication. Creation of oral controlled Release (CR) formulation is an endeavor to deliver the drug gradually into the gastrointestinal tract (GIT) and keep a powerful medication focus in the systemic circulation for an extensive period of time1.
Regardless of significant of the most recent a long time in creation of oral controlled drug delivery system, there has been restricted accomplishment on account of medications with helpless assimilation in the GIT.Moreover, GRDDS can improve the controlled release of medications by continuously delivering the medication for an all-encompassing period at the ideal rate and to the ideal assimilation site until the medication is totally delivered from the dosage form. GRDDS are possible for drugs that have low ingestion in the lower some portion of the GIT, are unstable and ineffectively dissolvable at soluble pH, have a short half-life, and show local action at the upper portion of the intestine for eradication of Helicobacter pylori. A few formulation techniques have been utilized to design successful controlled delivery GRDDS including superporous hydrogel, bio/mucoadhesive, raft-forming, magnetic, ionexchange, expandable, and low-and high-density systems.
Different formulation related factors, for example, polymer types (nonionic, cationic, and anionic polymers), polymer organization in dosage form, viscosity grade, molecular weight of the polymer, and medication dissolvability can influence the nature of the gastroretentive dosage form. Also, the physicochemical nature of excipients assumes a significant part in different GRDDS. For example, density of excipients and composition of effervescent agents are basic elements in effervescent floating system. On account of superporous hydrogel system, high expanding excipients, for example, crosspovidone and sodium carboxymethylcellulose are needed to shape a 7 superporous hydrogel. In like manner, measure factors can impact the nature of the gastroretentive dosage form, as the density of a tablet can be changed by the pressure during tableting. The fundamental motivation behind this is to give data on different GRDDS that have been created to date, just as the physiological condition of the stomach, appropriate medication candidate for GRDDS, factors influencing GRDDS, and in vitro and in vivo characterization of GRDDS2.
Moreover, scintigraphic considers including estimations of gastric emptying rates in healthy person subjects have uncovered that few physiological issues for example, inability to restrain and find the medication delivery system inside the ideal area of the GIT and the eccentric gastric exhausting time (around 8–12hrs) variable gastric motility makes the significant amount of medication be unabsorbed. And it also it diminishes the adequacy of the administered dose due to the incomplete medication release from the dosage form. The gastric emptying time of dosage form in people is influenced by a few components and hence wide between and intra-subject varieties are noticed.
The improvement of when day by day oral supported delivery dosage form is not sustained release of medications for 24hrs however additionally to broaden the presence of dosage form in the stomach or in the upper small intestine. Consequently, it is more attractive to design a controlled release drug delivery system (CRDDS) with broadened GIT residence time and medication release free of tolerant related factors, for example, age, race, sex, food dietary patterns and illness states, as they could truly influence the arrival of a medication from the CRDDS. GRDDS is a way to deal with delay gastric residence time, by focusing site-specific medication release in the upper gastrointestinal tract for nearby or systemic effects3.
Requirement for gastroretention:
GRDDS is a way to deal with prolong gastric retention time (GRT) particularly on account of strong intestinal movement, for example, in looseness of the bowels, drugs ingested through the stomach, targeting site-specific medication release in the upper gastrointestinal tract for neighbourhood or systemic effects, just as moderate substance delivery to go about as a supply and along these lines ensuring its ideal bioavailability. Clearly to accomplish gastric retention, the dosage form should have certain requirements. Fundamentally the dosage form should be capable to withstand the powers that are brought about by peristaltic waves in the stomach and the nonstop compressions to oppose early gastric emptying of drugs and moreover at the point when its motivation has been served, the device can leave the stomach effectively and freely4.
Advantages of gastroretention:
(1) The bioavailability of therapeutic agents can be altogether upgraded particularly for those which get used in the upper GIT by this gastroretentive drug delivery approach in contrast to the administration of non gastroretentive drug delivery.
(2) For drugs with generally short half life, sustained delivery may bring about a flip-flop pharmacokinetics and furthermore empower reduced frequency of dosing with improved patient compliance.
(3) Gastroretentive medication delivery can deliver prolong and sustain release of medications from dosage form which avail local treatment in the stomach and small intestine. Hence they are valuable in the treatment of issues identified with stomach and small intestine.
(4) The controlled, slow delivery of medication dosage form Gastroretentive dosage form gives adequate activity at the infected site, consequently small mizing or taking out systemic exposure of medications. This site-specific medication delivery decreases unfortunate effects of side effects5.
Medications which are unsatisfactory for GRDDS:
There are some circumstances where gastric retention is not an attractive option and won't profit by joining into gastric retention system, including drugs that are not stable in acidic conditions, medicates that have extremely restricted acidic solvency, drugs which go through first pass metabolism, sedates that are expected for specific release in the colon and non-steroidal anti-inflammatory drugs which cause gastric wounds. GRDDSs are those sorts of drugs that need adequately significant levels of liquids in the stomach and presence of food to postpone their gastric emptying period6.
Strategies for delaying drug transit through git:
1. Pharmacological approach - it includes the coadministration or consolidation of a medication into the dosage form. This medication delays gastrointestinal emptying. Examples incorporate antimuscarinic like propantheline.
2. Physiological approach - It utilizes natural materials or fat derivatives, for example, triethanolamine myristate, that stimulates the receptors present in the duodenum or jejunum to slow gastric emptying.
3. Pharmaceutical approach - Initial two methodologies are not utilized because of toxicity effects 7.
Current pharmaceutical technologies of GRDDS:
A. Low-density system:
Low-thickness/coasting systems are the most functional and widely examined gastroretentive dosage form. The floating system was first presented by Davis in 1968. In this system, the mass thickness of the dosage form is lower than that of the gastric liquid (1.004g/cm3).
This property permits the system to stay light in the stomach for a delayed timeperiod while the medication is delivered at the ideal rate from the system during the GRT. It represents the idea of low-thickness systems. These systems are characterized into two subtypes dependent on the component noneffervescent floating and effervescent floating systems8,9.
1. Non-effervescent floating system-In non-effervescent system, exceptionally swellable cellulose subordinates or gel-shaping polymers are utilized. The plan strategy of non-effervescent systems includes blending the medication in with a gel-shaping polymer. Different noneffervescent systems incorporate the hydrodynamically balanced system (HBS), single-and twofold layer skimming tablets, and microballoons/ empty microspheres. The HBS framework was first planned by Sheth and Tossounian in 198410.
It is a single unit dosage form made out of at least one gel-shaping hydrophilic polymers. HPMC, hydroxy propyl cellulose (HPC), hydroxyethylcellulose, sodium carboxymethylcellulose, carrageenan, agar, and alginic corrosive are a portion of the polymers that are utilized to plan the HBS system. In this system, the medication is blended in with the polymer and filled in the gelatin case11.
The floating tablet can be planned by uniform blending of the medication and gel-framing hydrophilic polymer, which hydrates and swells upon contact with the gastric liquid and keeps up the mass thickness of the tablet at <1gm/cm3. Subsequently, the low-thickness systems glide on the gastric liquid and delay the GRT. The normally utilized hydrophilic polymers in floating tablet incorporate HPMC, polyethylene oxide, HPC, and cellulose acetic acid derivation phthalate.
Wei et al. examined the bilayer drifting tablet containing a prompt delivery layer and supported delivery layer of the medication. The quick delivery layer contained a breaking down specialist, which helped the brief arrival of medication, though the supported delivery layer contained a hydrophilic polymer to control the medication discharge rate and furthermore gave the tablet lightness12.
Medication stacked microballoons/empty microspheres are detailed by basic dissolvable dissipation or dissolvable dispersion methods, and are numerous unit drifting systems. Polycarbonate, cellulose acetic acid derivation, calcium alginate, Eudragit S, agar, and low-methoxylated gelatin are ordinarily utilized polymers to plan microballons.
Different detailing factors, for example, the measure of polymer, proportion of plasticizer and polymer, and dissolvable can influence the coasting conduct and medication arrival of these sorts of dose structures. One disadvantage of the HBS is that this system, being a lattice definition, comprises of a mix of medication and low-thickness polymers. The delivery energy of the medication can't be changed without changing the coasting properties of the dosage form and vice-versa13.
2. Effervescent floating system - Effervescent floating systems incorporate a gas-creating specialist and unpredictable fluids. This methodology has been applied for single-and various unit frameworks. In the gas-producing drifting framework, bubbly specialists, for example, sodium bicarbonate, calcium carbonate, tartaric corrosive, and citrus extract are utilized in mix with hydrophilic polymers14.
At the point when this framework comes into contact with gastric liquid, CO2 is freed because of the response of the bubbly specialist with gastric liquid. The freed CO2 gas is ensnared in the hydrocolloid network, which gives the tablet lightness and impacts the medication discharge properties. In unstable fluid frameworks, unpredictable fluids, for example, ether and cyclopentane are brought into an inflatable chamber, which volatilize at internal heat level permitting swelling of the chamber in the stomach15.
Hydrophilic polymers are frequently used to control the medication discharge rate in this framework. Effervescent gliding frameworks can be arranged into single-and twofold layer effervescent floating tablets and numerous unit effervescent floating system. Single-layer effervescent tablets are defined by personally blending effervescent specialist, polymer, drug, and excipients.
Nonetheless, in bilayer effervescent coasting tablets, one layer includes the medication, polymer, and CO2 gas-creating specialist, while the other layer establishes a quick delivery drug and excipients without CO2 and polymer. In a new report, sodium bicarbonate in HPMC grid plan was utilized to improve the GRT by expanding the hydration volume of dose structure and expanding the surface region of medication dispersion. Moreover, an expansion in the measure of sodium bicarbonate diminished the medication discharge rate from the grid, which could be because of hindrance of the dispersion way by CO2 gas effervescence. Another examination additionally used this way to deal with assess the in vitro and in vivo practices of ciprofloxacin hydrochloride effervescence gliding tablets16,17.
Numerous unit effervescent floating tablets comprise of supported delivery pills as seeds encompassed by twofold layers. The inward layer contains effervescent specialists, for example, sodium bicarbonate, calcium carbonate, and tartaric corrosive while the external layer comprises of polymers with expanding properties. A low thickness system might be related with issues, for example, remaining together or being hindered in the GIT, which could create gastric aggravation. This system requires high liquid levels in the stomach to buoy and work adequately. Along these lines, drugs with aggravation impacts on the gastric mucosa are not reasonable contender for low-thickness system18,19.
B. High density system:
High-thickness systems have a thickness more noteworthy than that of gastric liquid. Generally utilized excipients of these systems incorporate barium sulfate, zinc oxide, iron powder, and titanium dioxide.
The densities of the tried dosages forms went from 0.9 to 10.5g/cm3. The creator presumed that high-thickness materials had slow GRTs than light-thickness materials. From that point, the effect of dosage form thickness on GRT has been examined. revealed that little high-thickness pellets can oppose gastric peristaltic developments because of their maintenance in the antrum rugae or folds, expanding the gastrointestinal plot time from 5.8 to 25h. Despite the fact that this system can possibly improve the GRT, it is hard to plan high-thickness pellets containing high-portion drugs20,21.
Also, a couple of clinical examinations on high-thickness pellet plans have been accounted for in the writing; accordingly, the clinical criticalness of these systems is as yet flawed. In this way, future bearings should be centered around creature studies to explore the clinical criticalness of such dosage forms22.
C. Expandable systems:
Expandable medication delivery systems are intended to have a more extended GRT through an expansion in their volume or shape. At first, they were utilized for veterinary purposes and, along these lines, their applications were stretched out to people. Three general setups should be considered for the legitimate working of the system: little size for simple oral admission, extended structure in the stomach to forestall section through the pyloric sphincter, and size decrease of the system after complete medication delivery to empower departure. This framework is likewise named as a "plug type system" since it can impede the pyloric sphincter. Extension of the system happens by two techniques, growing and unfurling, which take into account volume and shape change, separately. The fundamental instrument for expanding and medication discharge from the framework is dispersion. These frameworks use hydrophilic polymers (e.g., HPMC, polyethylene oxide, and carbopol) that can assimilate water from the gastric liquids and increment the volume of the system. Moreover, in unfurling system, the polymer and medication are in a collapsed/compacted state inside the gelatin case. At the point when they come into contact with the gastric liquid, gelatin is broken up and discharges the precisely favored extended arrangement.23-25
Diverse mathematical types of biodegradable polymer can be arranged and compacted inside a case. It is essential to choose a reasonable biodegradable polymer with a fitting atomic weight, thickness evaluation, and expanding properties to keep up the supported delivery profile of the dose structure26.
Different epic polymers can expand immediately in contact with the GI liquid. Sivaneswari et al. created and portrayed a novel expandable GRDDS of levetiracetam dependent on an unfurling component. In their investigation, the medication was stacked onto a polymeric fix made of HPMC, carbopol 934 P, and xanthan gum, which was intended to hold fast to the gastric mucosa, where the medication was delivered in a supported way27.
D. Superporous hydrogel systems:
In 1998, the superporous hydrogel was introduced as an alternate classification of water-permeable polymer system. This system has acquired prominence in the controlled-discharge definition because of its high mechanical strength and versatile properties. It has a pore size more noteworthy than 100 μm, and thus, it expands quickly to a balance size because of water take-up by slim wetting through various pores.28,29
The traditional hydrogel framework is a moderate cycle and requires a few hours to arrive at harmony; hence, the dosage form can be handily emptied from the stomach. Actually, the superporous hydrogel systems swell up to multiple times or more, and gain enough mechanical solidarity to withstand pressure by gastric compression, along these lines expanding the GRT. Exceptionally swellable polymers, for example, croscarmellose sodium and sodium alginate are utilized in these systems. Notwithstanding, these systems can be profoundly touchy to pH, and growing can be reversible because of changes in pH and poor mechanical strength of the dose30.
E. Raft forming system:
Raft forming systems are another kind of GRDDS, defined with effervescent excipients and gel shaping polymers to accomplish the supported medication conveyance. shows the idea of these systems, which fundamentally centers around accomplishing restricted impacts since floating rafts go about as bars among throat and stomach. Accordingly, they can be utilized for the powerful administration of gastric esophageal reflux illness31.
At the point when raft forming systems come into contact with gastric liquid, they swell and structure a gooey strong gel prompting the development of a constant layer named as raft. Fabregas et al. clarified the acid neutralizer raft forming gliding system. The creators utilized sodium alginate as a gel-framing polymer, and sodium bicarbonate and corrosive neutralizer as gas-producing specialists. Accordingly, CO2 gas is created that brings down the mass thickness of the framework, and thus, the pontoon glides on the gastric liquid32-35.
Different gastrointestinal mucoadhesive dosage forms, for example, dots, microspheres, films, containers, and tablets have been arranged and announced in the writing. Normally utilized mucoadhesive polymers incorporate carbopol, chitosan, sodium alginate, HPMC, polyethylene glycol, and poly (acrylic corrosive)36-39.
Mucoadhesive polymers help with restricting medication substances to the mucosal surfaces and drawing out the medication home time at the application site. An ideal mucoadhesive polymer is inactive, non-bothering, nontoxic, clings to the mucosal surface, and has site explicitness; and communicates with the mucin through electrostatic, disulfide, hydrogen, and hydrophobic holding. The mucoadhesive properties and cooperation strength of the polymer rely upon the sub-atomic weight, structure, adaptability of the polymeric chains, hydrogen holding limit, crossconnecting thickness, charge, focus, or hydration level of the polymer40-43.
CONCLUSION:
GRDDS can possibly improve the restorative viability of medications with thin assimilation windows, high solvency at acidic pH, and precariousness at basic pH. A careful comprehension of the life systems and physiological condition of the stomach, examinations concerning the effect of definition and cycle factors on dosage form quality is an essential for the fruitful plan of GRDDS. Despite the fact that different GRDDS, for example, bio/mucoadhesive, attractive, low-, and high-thickness frameworks have been accounted for in the writing, their clinical importance actually should be considered. From the drug angle, future bearings of GRDDS may have to zero in on a mix approach of GRDDS to accomplish better item quality. In addition, a QbD approach can be utilized to all the more likely comprehend the impacts of plan and cycle variable on item execution.
ACKNOWLEDGEMENTS:
The authors are highly thankful to the management of Sanskar Educational Group for their constant support.
CONFLICT OF INTEREST:
None.
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Received on 18.06.2023 Modified on 10.10.2023
Accepted on 10.01.2024 ©AandV Publications All Right Reserved
Res. J. Pharma. Dosage Forms and Tech.2024; 16(1):91-97.
DOI: 10.52711/0975-4377.2024.00015