INTRODUCTION:

Patent is a statutory right granted by patent office to the inventor of a novel, non-obvious and industrially useful invention. Patents are the legal protection for inventions, including new chemical entities discovered by research-based pharmaceutical companies. This protection allows a company time to recoup their significant investment in research and development. In return for such protection, a patent-holder discloses to the world patented research and science underlying the invention. The owner of a patent has the right to exclude others from making, using, offering for sale, or selling his or her invention for a period of 20 years from the filing of the patent application. The expiration of a patent removes the monopoly of the patent holder and then any pharmaceutical company can manufacture and sell that drug.

Many pharmaceutical companies have utilizes Gastroretentive Drug Delivery Approach that have been patented keeping in view of its commercial success. The development of Novel Gastroretentive Drug Delivery Approach has been a challenge to formulation scientists due to their inability to restrain and localize the system at targeted areas of the gastrointestinal (GI) tract [1]. Drugs which are easily absorbed from the gastrointestinal tract and those with short half-lives are quickly eliminated from the systemic circulation due to which frequent dosing is required. To overcome this problem, gastroretentive drug delivery systems which provide effective plasma drug concentration for longer periods thereby reducing the dosing frequency are being formulated. It also has an advantage of minimising the fluctuations in plasma drug concentration by delivering the drug in a controlled and reproducible manner [2].

ADVANTAGES[3, 4]

· Used for local action in the stomach.

· In the treatment of peptic ulcer disease.

· Used for the delivery of drugs with narrow absorption window in the small intestine.

· Reduced dosing frequency.

· Improved bioavailability of the drug.

· Used for drugs which are unstable in intestinal fluids

· Used to sustain the delivery of drug

· Used for maintaining the systemic drug concentration within the therapeutic window.

· Site specific drug delivery is also possible

DISADVANTAGES [5]

· Floating systems has limitation, that they require high level of fluids in stomach for floating and working efficiently. So more water intake is prescribed with such dosage form.

· In supine posture (like sleeping), floating dosage form may swept away (if not of larger size) by contractile waves. So patient should not take floating dosage form just before going to bed.

· Drugs having stability problem in high acidic environment, having very low solubility in acidic environment and drugs causing irritation to gastric mucosa cannot be incorporated into GRDDS.

· Bio/mucoadhesives systems have problem of high turnover rate of mucus layer, thick mucus layer and soluble mucus related limitations.

· Swellable dosage form must be capable to swell fast before its exit from stomach and achieve size larger than pylorus aperture. It must be capable to resist the housekeeper waves of Phase III of MMC.

REQUIREMENTS FOR THE GASTRORETENTIVE FORMULATIONS [6]

· Drugs acting locally in the stomach (Antacids and drugs for H. Pylori viz., Misoprostol)

· Drugs that are primarily absorbed in the stomach (Amoxicillin)

· Drugs that is poorly soluble at alkaline pH (Furosemide, Diazepam, Verapamil)

· Drugs with a narrow window of absorption (Cyclosporine, Methotrexate, Levodopa)

· Drugs which are absorbed rapidly from the GI tract (Metonidazole, tetracycline)

· Drugs that degrade in the colon (Ranitidine, Metformin HCl)

· Drugs that disturb normal colonic microbes (Antibiotics against Helicobacter pylori)

RECENT PLATFORM TECHNOLOGIES AND PATENT PROTECTION

Soctec™ Versatile Gastro-Retentive Platform[7]

Soctec™ is a versatile extended release gastro-retentive platform technology that has been designed to overcome many of the limitations of alternative available systems. Soctec™ is an easy to swallow elongated capsule as presented in fig 1. It has an integral buoyancy chamber and a counter-balanced denser ballast, to ensure that it floats upright in the stomach fluids as soon as it is swallowed (fig 2).

Fig.1: Inner Capsule Architecture

Normally the contents of the stomach are crushed by peristaltic contractions and the contents are rapidly expelled through the pylorus into the duodenum. However, owing to its shape and physical properties, Soctec™ could be retained in the stomach for more than 9 hours. During this time Soctec™ releases its drug load at a pre-determined rate, allowing absorption in the small intestine upper segments.

Fig.2: Capsule Position in Stomach

Soctec™ can be used with a range of drugs that have a narrow absorption window and are preferentially absorbed in the upper intestine segments. It can also improve the bioavailability of drugs that are degraded by the alkaline pH of the lower gastro-intestinal tract. It is also suitable for drugs that are targeted for local action in the stomach and small intestine. Skyepharma filed patented application on this mechanism of Soctec™.

Accordion Pill™ Technology[8]

The Accordion Pill™ is a unique gastro retentive formulation composed of pharmaceutical biodegradable polymeric films. It is a multi-layer, planar structure, folded to an accordion shape into a standard size, regular capsule as presented in fig 3.

Upon reaching the stomach, the capsule dissolves, the Accordion Pill™ unfolds and is retained in the stomach for up to 12 hours, under regular calorie diets. While in the stomach, the Accordion Pill™ releases the drug in a controlled manner towards the upper part of the gastrointestinal tract.

The Accordion Pill™ is designed for drugs that are characterized by one of the following:

• Narrow Absorption Window (poor colonic absorption)

• Poor solubility, BCS class II or IV

• Act locally, in the stomach or in the upper part of the GI tract

• Adverse effects correlate with the drug reaching the distal parts of the GI tract

Retaining the dosage form in the stomach and releasing the drug in a controlled manner enable prolonged and continuous absorption phase of the drug in the upper part of the gastrointestinal tract, resulting in improved efficacy and safety profile, as well as reducing frequent daily dosing.

The Gastro-retentive drug formulation (GRDF) enhances patient care by significantly improving compliance via less frequent dosing. Better bioavailability will deliver enhanced efficacy and reduce toxic side effects. The GRDF platform is non-drug specific, which means it can serve as a platform to include large amounts of a variety of active agents and drugs with different physicochemical properties. To date, this has been proven on dosages of up to 350 mg in a single capsule. Because the active ingredients are released in a slow, controlled manner over an extended period of time, the pharmacology profile improves significantly.

Patented literature on this mechanism of Accordion Pill™ has been outlined in below Table 1.

Fig.3: Accordion Pill Technology

Table 1: Patent Literature of Accordion Pill™

PATENT/APPLICATION

NUMBER

DISCLOSURE

US 8,298,574

Intec Pharma

This patent discloses methods, systems and apparatuses are provided for producing delivery devices, preferably for oral intake of an agent. In the broadest aspect, the method comprises assembling one or more layers comprising one or more materials with an agent or an agent-releasing formulation to form an intergraded, preferably laminated device; folding said integrated delivery device to form a folded integrated delivery device; and at least partially enclosing said folded delivery device to a form suitable for oral delivery. Preferably, the integrated device comprise a first external layer of a first material; a frame of a second material mounted on the first external layer; an agent-releasing formulation housed within the frame; and a second external layer of the first material mounted on the frame.

US 8,609,136

Intec Pharma

This patent provided methods, systems and apparatuses for producing delivery devices, for example, for oral intake of an agent. The method can include assembling one or more layers including one or more materials with an agent or an agent-releasing formulation to form an intergraded device; folding the intergrated delivery device to form a folded integrated delivery device; and at least partially enclosing the folded delivery device to a form suitable for oral delivery.

US 8,753,678

Intec Pharma

This patent claims a method for producing an agent delivery device for oral intake comprising:

assembling one or more layers comprising one or more materials with an agent or an agent-releasing formulation into a generally planar assembly to form an integrated device;

folding said integrated delivery device to form a folded integrated delivery device defining a first axis, such that the folded device has folds of increasingly smaller amplitudes upon extending away from the first axis so as to form a partially rounded cross section; and

at least partially enclosing said folded delivery device to a form suitable for oral delivery.

Fig.4: Gastro Retentive Innovative Device (GRID)

Table 2: Patent Literature of GRID™

PATENT/APPLICATION

NUMBER

DISCLOSURE

US 8,012,496

Sun Pharmaceutical

This patent discloses a gastric retention controlled drug delivery system comprising:

(a) a controlled release core comprising a drug, a highly swellable polymer and a gas generating agent, said core being capable of swelling and achieving flotation rapidly while maintaining its phys. integrity in gastrointestinal fluids for prolonged periods, and

(b) a rapidly releasing coat composition comprising the same drug as in the core and pharmaceutically acceptable excipients, wherein the coating composition surrounds the core such that the system provides a biphasic release of the drug in gastrointestinal fluids.

The gastric retention controlled-release tablets were obtained by mixing baclofen 20.0 mg, lactose 30.0 mg, hydroxyethyl cellulose 400.0 mg, sodium starch glycolate 150.0 mg, sodium bicarbonate 40.0 mg, and hydroxypropyl Me cellulose 136.0 mg, granulating the mixture with silicified microcryst. cellulose 90.0 mg, talc 24.0 mg, polyethylene glycol 10.0 mg, and hydroxypropyl Me cellulose 100.0 mg to prep. a core, and coating the core with a mixture containing baclofen 10.0 mg and hydroxypropyl Me cellulose 45.0 mg. Tablets prepd. achieved flotation in about 10 min.

US 20080107732

Sun Pharmaceutical

This patent application provides a novel gastric retention system in the form of a tablet or a capsule coated with an expandable coating, more particularly, with an expandable coating comprising a film-forming polymer and an expandable component.

The gastric retention system is used for controlling appetite and therefore obesity.

A gastric retention drug delivery system was prepared containing 750 mg metformin hydrochloride per coated tablets.

More than 95% of the tablets were dissolved in pH = 3.0, and 4.5.

IN 2010MU00300

Sun Pharmaceutical

The present invention provides a gastric retention controlled drug delivery system comprising:

(a) a controlled release core comprising a drug, a highly swellable polymer and a gas generating agent,

(b) a rapidly releasing coat composition comprising the same drug as in the core and pharmaceutically acceptable excipients. A gastric retention controlled drug delivery system contained lactose, hydroxyethyl cellulose, sodium starch glycolate, sodium bicarbonate, hydroxypropyl methylcellulose, extragranular silicified microcryst. cellulose, talc, polyethylene glycol, hydroxypropyl methylcellulose in the core, and baclofen, hydroxypropyl methyicellulose in the coat.

Fig.5: Multiple Polymers Hydrophilic Matrix Technology

Table 3: Patent Literature of MPHM Technology

PATENT/APPLICATION

NUMBER

DISCLOSURE

WO0006129 A1

Merck Sante

The PCT Application discloses a tablet for extended release of a drug in the stomach, comprising granules containing said drug in a hydrophilic matrix, said granules being coated with a coating comprising a source of a carbon dioxide and said coated granules being blended with an agent inducing the release of carbon dioxide and (a) tabletting aid(s).

US 6,660,300

Bristol Myers Squibb

A biphasic controlled release delivery system for pharmaceuticals which have high water solubility, such as the antidiabetic metformin HCl salt, is provided which provides a dosage form that has prolonged gastric residence so that a dosing regimen of at least one gram metformin, once daily, may be achieved while providing effective control of plasma glucose. The delivery system includes (1) an inner solid particulate phase formed of substantially uniform granules containing a pharmaceutical having a high water solubility, and one or more hydrophilic polymers, one or more hydrophobic polymers and/or one or more hydrophobic materials such as one or more waxes, fatty alcohols and/or fatty acid esters, and (2) an outer solid continuous phase in which the above granules of inner solid particulate phase are embedded and dispersed throughout, the outer solid continuous phase including one or more hydrophobic polymers, one or more hydrophobic polymers and/or one or more hydrophobic materials such as one or more waxes, fatty alcohols and/or fatty acid esters, which may be compressed into tablets or filled into capsules. Methods for forming the so-described biphasic controlled release delivery system and using such biphasic controlled release delivery system for treating diabetes are also provided.

US 6,475,521

Bristol Myers Squibb

This patent claims a pharmaceutical formulation comprising

(1) an inner solid particulate phase, and

(2) an outer solid continuous phase in which particles of the inner solid particulate phase are dispersed and embedded, the particles of the inner solid particulate phase comprising

(a) a pharmaceutical having a high water solubility selected from metformin or a pharmaceutically acceptable salt thereof; and

(b) an extended release material, and the outer solid continuous phase comprising an extended release material, wherein the total extended release material content in both the inner solid particulate phase and the outer solid continuous phase is within the range from about 25 to about 75% by weight of the pharmaceutical formulation.

Table 4: Patent Literature of Depomed Technology

PATENT/APPLICATION NUMBER	PATENT CLAIMS
US 6,340,475 Depomed	A controlled-release oral drug dosage form for releasing a drug whose solubility in water is greater than one part by weight of said drug in ten parts by weight of water, said dosage form comprising a solid polymeric matrix with said drug dispersed therein at a weight ratio of drug to polymer of from about 15:85 to about 80:20, said polymeric matrix being one that swells upon imbibition of water thereby attaining a size large enough to promote retention in the stomach during said fed mode, that releases said drug into gastric fluid by the dissolution and diffusion of said drug out of said matrix by said gastric fluid, that upon immersion in gastric fluid retains at least about 40% of said drug one hour after such immersion and releases substantially all of said drug within about eight hours after such immersion, and that remains substantially intact until all of said drug is released.
US 6,488,962 Depomed	A controlled-release oral drug dosage form for releasing a drug into at least a portion of a region defined by the stomach and the upper gastrointestinal tract, said dosage form comprising a solid monolithic matrix with said drug contained therein, said matrix being non-circular in shape and having first and second orthogonal axes of unequal length, said matrix being one that swells in an unrestricted manner along both such axes upon imbibition of water, the longer such axis having a maximum length of 3.0 cm when said matrix is unswollen, and the shorter such axis achieving a minimum length of 1.2 cm within one hour of immersion of said dosage form in water and wherein said matrix has a shape which when projected onto a plane, is either an oval or a parallelogram.
US 6,635,280 Depomed	A controlled-release oral drug dosage form for releasing a drug whose solubility in water is greater than one part by weight of said drug in ten parts by weight of water, said dosage form comprising one or more polymers forming a solid polymeric matrix with said drug incorporated therein at a weight ratio of drug to polymer of from 15:85 to 80:20, said dosage form being one that when swollen in a dimensionally unrestricted manner as a result of imbibition of water is of a size exceeding the pyloric diameter in the fed mode to promote retention in the stomach during said fed mode, that releases said drug into gastric fluid by the dissolution and diffusion of said drug out of said matrix by said gastric fluid, that upon immersion in gastric fluid retains at least about 40% of said drug one hour after such immersion and releases substantially all of said drug after such immersion, and that remains substantially intact until substantially all of said drug is released.
US 6,723,340 Depomed	A controlled-release tablet for releasing a drug into at least a portion of a region defined by the stomach and the upper gastrointestinal tract, said tablet comprising a solid monolithic matrix with said drug dispersed therein, said matrix comprising a combination of poly(ethylene oxide) and hydroxypropyl methylcellulose at a weight ratio that causes said matrix to swell upon contact with gastric fluid to a size large enough to provide gastric retention, wherein; said drug has a solubility in water that exceeds one part of said drug per ten parts of water, by weight, and wherein; said poly(ethylene oxide) has a viscosity average molecular weight of from about 2,000,000 to about 10,000,000 daltons, and wherein said hydroxypropyl methylcellulose has a viscosity of from about 4,000 centipoise to about 200,000 centipoise, measured as a 2% solution in water.
US 8,252,332 Depomed	A dosage form, comprising a matrix comprising gabapentin, wherein upon ingestion of the dosage form gabapentin is released from the matrix into the upper gastrointestinal tract over about 5-12 hours at a rate sufficient to achieve a lower maximum plasma concentration than that provided by an immediate release dosage form comprising an equal amount of gabapentin, and bioavailability of gabapentin is at least 80% of that provided by the immediate release dosage form comprising an equal amount of gabapentin as measured by the area under the plasma concentration-time curve, AUC_inf.
US 7,731,989 Depomed	A dosage form, comprising between about 100 mg to about 4800 mg of gabapentin or pharmaceutically acceptable salt thereof, dispersed in a single polymer matrix comprising at least one swellable hydrophilic polymer that swells unrestrained dimensionally by imbibing water to increase its size to promote gastric retention of the dosage form in a stomach in a fed mode, wherein upon contact with water, gabapentin is released by diffusion from the dosage form over a period of at least five hours and at least 40 wt % of the gabapentin is retained in the dosage form 1 hour after administration.
US 8,192,756 Depomed	A dosage form, comprising: comprising from 100 mg to 4800 mg of therapeutically effective amount of gabapentin or pharmaceutically acceptable salt thereof, dispersed in a single matrix wherein the matrix comprises at least one swellable hydrophilic polymer that swells unrestrained dimensionally by imbibing water to increase its size to promote gastric retention of the dosage form in the stomach in a fed mode, wherein upon once-daily or twice-daily ingestion of the dosage form gabapentin is released from the matrix over a period of at least five hours wherein at least 40 wt% of the gabapentin is retained in the matrix one hour after administration, and wherein the gabapentin is released at a rate sufficient to achieve a lower maximum plasma concentration (C_max) compared to an equal dose of gabapentin provided by an immediate release dosage form, and without loss in bioavailability as measured by the area under the curve (AUC_infinity) as compared to the bioavailability which is achieved from an immediate release dosage form comprising the same dose of gabapentin.
US 8,333,992 Depomed	A dosage form, comprising: a matrix comprising gabapentin, wherein upon ingestion of the dosage form by a human subject gabapentin is released from the matrix into the upper gastrointestinal tract over about 5-12 hours at a rate sufficient to achieve a lower maximum plasma concentration than that provided by an immediate release dosage form comprising an equal amount of gabapentin, and bioavailability of gabapentin is at least 80% of that provided by the immediate release dosage form comprising an equal amount of gabapentin as measured by the area under the plasma concentration-time curve, AUC_inf.

Gastrointestinal Permeation Enhancement Technology [12]

Merrion Pharmaceutical’s Gastrointestinal Permeation Enhancement Technology (GIPET) is a unique approach allows drugs that currently can only be given parenterally (injectable) to be converted into oral (tablet/capsule) forms, as well as improving the absorption of current oral drugs. GIPET uses specifically designed oral formulations of patented absorption enhancers which activate micelle formation facilitating transport of drug and substantially increasing absorption with good reproducibility and a strong safety profile.

Gastrointestinal Retention System (GIRES) [12]

Another Merrion’s GIRES technology consists of a controlled-release dosage form inside an inflatable pouch, which is placed in a drug capsule for oral administration. Upon dissolution of the capsule, a gas-generating system inflates the pouch in the stomach. In clinical trials the pouch has been shown to be retained in the stomach for 16-24 hours.

Leonard et al mentioned as overcoming the poor oral absorption of high-value therapeutics, including peptides, is one of the most important and challenging goals in drug delivery. Gastro-Intestinal Permeation Enhancement Technology attempts to address this issue by safely delivering drugs across the small intestine in therapeutically relevant concentration. GIPET is based primarily on promoting drug absorption through the use of medium-chain fatty acids, salts, and derivatives. (GIPET I), formulated in enteric-coated tablets. GIPET II comprises mixture of mono- and diglyceride fatty acids in a solid dose format. Importantly, these excipients are generally regarded as safe (GRAS) and do not result in a change in chemical composition of the active ingredient. To date, 300 volunteers have been administered GIPET formulations in 16 Phase I studies of 6 sep. drugs comprising both single- and repeat-dosing regimes. Oral bioavailability of alendronate, desmopressin, and low molecular weight heparin in humans was increased using GIPET formulations compared to unformulated controls. GIPET was well tolerated by human subjects. Using fluxes of markers of epithelial permeability, effects of GIPET on the human intestine were shown to be rapid, short-lived, and reversible in vivo. The combined data suggests that GIPET formulations have a real potential as a platform technology for safe and effective oral drug delivery of poorly absorbable drugs [13].

Micropump Technology [14]

Flamel’s Micropump® platform permits either extended, or both delayed and extended, delivery of small molecule drugs via the oral route. Micropump consists of a multiple-particulate system containing 5,000 to 10,000 microparticles per capsule or tablet. The 200-500 microns diameter-sized microparticles release the drug at an adjustable rate and over an extended period of time.

Fig.6: Micropump Technology

Micropump’s Key Attributes:

· Extended release in the Gastro-Intestinal (“GI”) tract allowing mean plasma residence times to be extended for up to 24 hours,

· Potentially improved efficacy (by extending therapeutic coverage),

· Potentially reduced toxicity and/or side effects (by reducing Cmax or peak drug concentration in the plasma, or by reducing intra- and inter-patient variability),

· Improved patient compliance (by reducing frequency of administration),

· Applicable to poorly soluble (< 0.01mg/L) as well as highly soluble (> 500g/L) and to low dose (e.g. 4 mg) or high dose (e.g. 1,000 mg) drugs,

· Excellent mouth feel,

· Taste masking properties.

Patented literature on this mechanism has been outlined in below Table 5.

Table 5: Patent Literature of Micropump Technology

PATENT/APPLICATION NUMBER	DISCLOSURE
US 6,022,562 Flamel	This patent relates to microcapsules for the oral administration of medicinal and/or nutritional active principles (AP), which are smaller than or equal to 1000 .mu.m in size. These microcapsules consist of particles which are coated with a coating material consisting of a mixture of a film-forming polymer derivative, a hydrophobic plasticizer, a functional agent and a nitrogen-containing polymer. These microcapsules are also characterized by their ability to remain in the small intestine for a long time (at least 5 hours) and to allow, during the residence, release and absorption of the AP. The invention also relates to a process for the production of the said microcapsules.
US 8,101,209 Flamel	This patent discloses The invention relates to a microparticulate system for the delayed and controlled release of active principles (AP) whose absorption window in vivo is essentially limited to the upper parts of the gastrointestinal tract, this system being intended for oral administration. The object of the invention is to provide a system ensuring that the AP is released with certainty by means of a dual mechanism of "time-dependent" and "pH-dependent" release. To achieve this object, the invention proposes a multimicrocapsular oral galenical form which is designed so as to guarantee therapeutic efficacy, and in which the release of the AP is governed by a dual release triggering mechanism that is "time-triggering" and "pH-triggering". This system comprises of microcapsules (200 to 600 .mu.m) comprising a core of AP coated with a film (maximum 40% by weight) comprising a hydrophilic polymer A (Eudragit™ L) and a hydrophobic compound B (vegetable wax, melting point=40-90°C.), B/A being between 0.2 and 1.5. These microcapsules have a dissolution behavior in vitro such that, at a constant pH of 1.4, a latency phase of between 1 and 5 hours is observed, followed by a release of the AP, and such that the change from pH 1.4 to pH 6.8 results in a release of the AP without a latency period in vitro.
US 8,734,850 Flamel	The field of the invention is that of oral pharmaceutical medicinal products or compositions, more particularly of the type of those comprising one or more active principles. The aim of the invention is to provide an improved oral medicinal product that can be administered in one or more daily doses, with modified release of active principle (in particular an active principle), for improving the prophylactic and therapeutic efficacy of such a medicinal product. This aim is achieved by means of the multimicrocapsular oral pharmaceutical form according to the invention in which the release of the AP is controlled by means of a double mechanism of triggering the release: "time triggering" and "pH triggering". This medicinal product comprises microcapsules with modified release of active principle, each containing a core comprising the active principle and one or more swelling agents, and at least one coating making possible the modified release of the active principle.

Table 6: Gastroretentive products available in the market

Product Name	Active Ingredient	Technology	Company
Zanocin OD	Ofloxacin	Effervescent floating system	Ranbaxy
Riomet OD	Metformine HCl
Cifran OD	Ciprofloxacin
Inon Ace Tablets	Siméthicone	Foam based floating system	Sato Pharma
Gabapentin GR	Gabapentin	Polymer-based swelling technology: AcuForm™	Depomed
Proquin XR	Ciprofloxacin
Glumetza	Metformin HCl
Metformin GR	Metformin HCl
Prazopress Xl	Prazosin HCl	Effervescent and swelling-based floating system	Sun Pharma
Metformin Hcl LP	Metformin HCl	Minextab Floating®	Galenix
Cafeclor LP	Cefaclor
Tramadol LP	Tramadol
Cipro XR	Ciprofloxacin HCl and Betaine	Erodible matrix based system	Bayer
Baclofen GRS	Baclofen	Coated multi-layer floating and swelling system	Sun Pharma
Coreg CR	Carvedilol	Gastro retention with osmotic system	Glaxosmithkline
Liquid gaviscon	Alginic acid and Sodium bicarbonate	Effervescent floating liquid alginate preparation	Reckitt Benckiser
Valrelease	Diazepam	Floating capsule	Roche
Cytotec	Misoprostol	Bilayer floating capsule	Pharmacia Ltd.
Topalkan	Aluminum Mg Antacid	Floating liquid alginate	Pierre Fabre
Xifaxan	Rifaximin	Bioadhesive Tablets	Lupin
Conviron	Ferrous Sulphate	Colloidal gel forming floating system	Ranbaxy

CONCLUSION:

In fast growing business model, technological innovation and patent protection go hand in hand. Patents have become a required asset for most high-tech businesses and there technologies. This article provides information regarding the patent aspects of some current gastroretentive drug delivery systems. It is evident from the above data that the pharmaceutical and technological companies are more focusing on strong patent protection for their novel and inventive gastroretentive drug design developments to get maximum benefit from the market.

ACKNOWLEDGMENT:

The authors were thankful to Wockhardt Research Centre, Aurangabad and Dr. Babasaheb Ambedkar Marathwada University, Aurangabad for providing the necessary support to carry out this survey.

CONFLICT OF INTERESTS:

Declared None

REFERENCES:

(1) Marinaganti RK. A Comprehensive Review on Gastro Retentive Drug Delivery System; Acta Chimica Pharmaceutica and Indica; 2013, 3(2): 149-164

(2) Allena RT. A Comprehensive Review on Gastroretentive Drug Delivery Systems; International Journal of Research in Pharmaceutical and Biomedical Sciences; 2012; 3 (3): 1285-1293

(3) Debjit B. Floating drug delivery system- A review. Der Pharmacia Lettre; 2009;1(2):199-218.

(4) Vyas SP. Controlled Drug Delivery: Concepts and Advances, Vallabh Prakashan, 196-217

(5) Joseph R. Controlled Drug Delivery, Fundamentals and Applications, 2nd Edition, Revised and Expanded, Marcell. Dekker Inc., New York (2009).

(6) Pandey A. A Review on current approaches in gastro retentive drug delivery system; Asian Journal of Pharmacy and Medical Science; 2012; 2(4): 60-77

(7) http://www.skyepharma.com/Technologies/Oral_drug_delivery_technologies/Soctec/ Default.aspx?id=78

(8) http://intecpharma.com/technology/

(9) http://www.sunpharma.in/gastro-retentive.htm

(10) http://www.sanofidiabetes.in/cepatin-doctor.aspx#Unique

(11) http://www.depomed.com/technology

(12) http://www.evaluategroup.com/View/4527--co-coInfo/Company/

(13) Leonard TW. Promoting absorption of drugs in humans using medium-chain fatty acid-based solid dosage forms: GIPET; Expert Opin Drug Deliv. 2006 Sep;3(5):685-92.

(14) http://www.flamel.com/drug-delivery-platforms/micropump/

(15) Srikanth MV. Gastroretentive drug delivery systems: novel approaches and its evaluation; International Journal of Pharmaceutical Sciences Review and Research; 2011; 10 (1): 203-216

(16) http://www.wikinvest.com/stock/Penwest_Pharmaceuticals _(PPCO)/Drug_Delivery Technologies

(17) http://patft.uspto.gov/netahtml/PTO/srchnum.htm (Patent Number)

Received on 16.11.2015 Modified on 26.11.2015

Res. J. Pharm. Dosage Form. & Tech. 8(1): Jan.-Mar. 2016; Page 15-23

DOI: 10.5958/0975-4377.2016.00003.3