thin film drug administration using a dissolving film or oral strip medicine to administer the drug through oral absorption (buccal or sublingually) and/or through the intestine small (automatically). A film is prepared using a hydrophilic polymer that rapidly dissolves on the tongue or buccal cavity, delivering the drug to the systemic circulation through dissolution when contact with the liquid is made.
Therapeutic drug-thinning has emerged as an advanced alternative to traditional tablets, capsules and fluids often associated with prescription and OTC drugs. Similar in size, shape and thickness to stamps, thin film strips are usually designed for oral administration, with users placing strips on or under the tongue (sublingual) or along the inside of the cheek (buccal). This drug delivery option allows the drug to bypass the first lane metabolism thus making the drug more bioavailable. When the strip is soluble, the drug may enter enteric bloodstream, buccally or sublingually. Evaluate the delivery of systemic transmucosal drugs, the buccal mucosa is the preferred area compared with the sublingual mucosa.
Different buccal products have been marketed or proposed for certain diseases such as trigeminal neuralgia, Meniere's disease, diabetes, and addiction. There are many non-drug commercial products that use thin films like Mr. Mint and Listerine PocketPaks are refreshing lines that are refreshing. Since then, thin film products for other air fresheners, as well as a number of flu, flu, anti-snoring and gastrointestinal drugs have entered the market. Currently there are several projects in development that will provide prescription drugs using thin film dosage forms.
Oral drug strip formulations involve the application of both aesthetic and performance characteristics such as polymer strip-forming, plasticizers, pharmaceutical active ingredients, sweetening agents, saliva stimulant agents, flavoring agents, dye agents, stabilizing and thickening agents. From a regulatory perspective, all excipients used in oral drug strip formulations must be approved for use in oral pharmaceutical preparations.
Video Thin-film drug delivery
Development of oral drug strips
Strips form polymers
The polymer used must be non-toxic, non irritating and does not contain dissolved impurities. It should have good wetting and spreading properties. The polymer should show adequate skin, shear strength and tensile strength. Polymers should be readily available and not too expensive. The film should be hard enough so there will be no damage when handling or during transportation. The combination of microcrystalline cellulose and maltodextrin has been used to formulate Oral Pyoxicam Strips made with hot melt extrusion technique. Pullulan has become the most widely used film (used in Listerine PocketPak, Benadryl, etc.)
Plasticizers
Plasticizer is an essential ingredient of OS formulation. This helps to increase strip flexibility and reduce strip fragility. Plasticizer significantly improves strip properties by reducing the polymer glass transition temperature. Glycerol, Propylene glycol, low molecular weight polyethylene glycol, phthalate derivatives such as dimethyl, diethyl and dibutyl phthalate, Citrate derivatives such as tributyl, triethyl, acetyl citrate, triacetin and castor oil are some commonly used plasticizer fillers.
Active pharmaceutical ingredients
Because the size of the dosage form has its limitations, high dose molecules are difficult to include in the OS. Generally 5% w/w up to 30% w/w of active pharmaceutical ingredients can be incorporated in oral strips.
Sweeting, flavoring, and coloring
An important aspect of thin film drug technology is its taste and color. Sweetness in the formulation is more important in the case of pediatric populations. Natural sweeteners as well as artificial sweeteners are used to improve the taste of mouth dissolving formulation due to the change of taste from individual to individual. Pigments such as titanium dioxide are included for coloring.
Stabilizer and thickening agent
Stabilizer and thickening agents are used to increase the viscosity and viscosity of the dispersion or solution of strip preparation or suspension prior to casting. Uniformity of drug content is a requirement for all dosage forms, especially those containing low-dose drugs. To meet this requirement uniquely, thin film formulations contain uniform drug dispersion throughout the manufacturing process. Because these criteria are important for the quality of thin films and final pharmaceutical dosage forms, the use of Laser Scanning Confocal Microscopy (LSCM) is recommended to follow the manufacturing process.
Verbal strip in development
An increasing number of film-based therapies are under development, including:
- Montelukast is indicated for the treatment of asthma and allergies, is being developed for use as a film by Monosol Rx.
- Midatech, a company specializing in nanotechnology, partnered with Monosol Rx to create film-based insulin. (Sachs Associates, CEP's 5th Annual European Life Science Forum for Partnership and Investing 6-7 March 2012. Zurich, Switzerland.)
- Rizatriptan is indicated for migraine treatment, is being developed for use as a film by Monsoon Rx and Zim Laboratories Ltd.
- Monosol Rx also develops testosterone-based therapy for the treatment of male hypogonadism. The product is currently in phase 1.
- Bachelor of biomedical engineering students at Johns Hopkins University have created a new drug delivery system based on the thin-film technology used by breathing freshener. Mixed with vaccines against rotavirus, strips can be used to provide vaccines for infants in poor areas.
Other molecules such as Sildenafil citrate, Tadalafil, Methylcobalamin and Vitamin D3 were also developed by Zim Laboratories Ltd.
Maps Thin-film drug delivery
References
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Hariharan, Madhu; Bogue, B. Arlie (February 2009). "Orally Eliminates Film Strips (ODFS): The Final Evolution of Dissolving Solution Forms". Drug Delivery Technology . Montville, New Jersey. 9 (2): 24-29. ISSNÃ, 1537-2898. OCLCÃ, 48060225. - "Drug Delivery Via Scripping Strip". Drug Discovery & amp; Development . 10 (7): 10. 2007. ISSNÃ, 1524-783X.
- Dixit, RP; Puthli, SP (2009). "Oral strip technology: overview and future potential". Controlled Release Journal . 139 (2): 94-107. doi: 10.1016/j.jconrel.2009.06.014. PMID 19559740.
- Patel, P; Makwana, S; Jobanputra, U (2011). "Sublingual route for systemic ondansetron delivery" (PDF) . Int J Drug Dev & amp; Research . 3 (4): 36-42.
External links
- How do you want your flu remedy? - Associated Press (10/10/05)
Source of the article : Wikipedia