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Orally dissolving strips and pods: A new approach to oral drug delivery system


Review the research behind Mood Dialers™, THC cannabis and CBD hemp strips and pods for instant delivery.

Offered by CANADEEN Corporation, an affiliate of First Jersey Cannabis Corporation, is commercially developing, manufacturing, and marketing a new category of edibles called Mood Dialers™. The primary brands THCsmarties™ and CBDsmarties™ are offered in four flavors. Known as lingual, sublingual, and buccal, they are absorbed directly into the bloodstream without going through the digestive system.

ABSTRACT

Recently, fast dissolving films are gaining interest as an alternative of fast dissolving tablets. The films are designed to dissolve upon contact with a wet surface, such as the tongue, within a few seconds, meaning the consumer can take the product without need for additional liquid. This convenience provides both a marketing advantage and increased patient compliance. As the drug is directly absorbed into systemic circulation, degradation in gastrointestinal tract and first pass effect can be avoided. These points make this formulation most popular and acceptable among pediatric and geriatric patients and patients with fear of choking. Over-the-counter films for pain management and motion sickness are commercialized in the US markets. Many companies are utilizing transdermal drug delivery technology to develop thin film formats. In the present review, recent advancements regarding fast dissolving buccal film formulation and their evaluation parameters are compiled.

Keywords: Fast dissolving films, oral mucosa, permeability, solvent casting, solvent casting and disintegration

INTRODUCTION

The oral route is one of the most preferred routes of drug administration as it is more convenient, cost effective, and ease of administration lead to high level of patient compliance. The oral route is problematic because of the swallowing difficulty for pediatric and geriatric patients who have fear of choking. Patient convenience and compliance oriented research has resulted in bringing out safer and newer drug delivery systems. Recently, fast dissolving drug delivery systems have started gaining popularity and acceptance as one such example with increased consumer choice, for the reason of rapid disintegration or dissolution, self-administration even without water or chewing. Fast dissolving drug delivery systems were first invented [Figures ​[Figures11 and ​and2]2] in the late 1970s as to overcome swallowing difficulties associated with tablets and capsules for pediatric and geriatric patients. Buccal drug delivery has lately become an important route of drug administration. Various bioadhesive mucosal dosage forms have been developed, which includes adhesive tablets, gels, ointments, patches, and more recently the use of polymeric films for buccal delivery, also known as mouth dissolving films. The surface of buccal cavity comprises of stratified squamous epithelium which is essentially separated from the underlying tissue of lamina propria and submucosa by an undulating basement membrane. It is interesting to note that the permeability of buccal mucosa is approximately 4-4,000 times greater than that of the skin, but less than that of the intestine. Hence, the buccal delivery serves as an excellent platform for absorption of molecules that have poor dermal penetration.[3] The primary barrier to permeability in otiral mucosa is the result of intercellular material derived from the so-called ‘membrane coating granules’ present at the uppermost 200 μm layer. These dosage forms have a shelf life of 2-3 years, depending on the active pharmaceutical ingredient but are extremely sensitive to environmental moisture. An ideal fast dissolving delivery system should have the following properties: High stability, transportability, ease of handling and administration, no special packaging material or processing requirements, no water necessary for application, and a pleasant taste. Therefore, they are very suitable for pediatric and geriatric patients; bedridden patients; or patients suffering from dysphagia, Parkinson's disease, mucositis, or vomiting. This novel drug delivery system can also be beneficial for meeting current needs of the industry. Rapidly dissolving films (RDF) were initially introduced in the market as breath fresheners and personal care products such as dental care strips and soap strips. However, these dosage forms are introduced in the United States and European pharmaceutical markets for therapeutic benefits. The first of the kind of oral strips (OS) were developed by the major pharmaceutical company Pfizer who named it as Listerine® pocket packs™ and were used for mouth freshening. Chloraseptic® relief strips were the first therapeutic oral thin films (OTF) which contained 7 benzocaine and were used for the treatment of sore throat. Formulation of fast dissolving buccal film involves material such as strip-forming polymers, plasticizers, active pharmaceutical ingredient, sweetening agents, saliva stimulating agent, flavoring agents, coloring agents, stabilizing and thickening agents, permeation enhancers, and superdisintegrants. All the excipients used in the formulation of fast dissolving film should be approved for use in oral pharmaceutical dosage forms as per regulatory perspectives.

CLASSIFICATION OF FAST DISSOLVING TECHNOLOGY

For ease of description, fast dissolve technologies can be divided in to three broad groups.

  • Lyophilized systems.

  • Compressed tablet-based systems.

  • OTF.

Lyophilized systems

This system has been by far the most successful among them in terms of sales value, sales volume, and number of worldwide product approvals. The technology around these systems involves taking a suspension or solution of drug with other structural excipients and, through the use of a mould or blister pack, forming tablet-shaped units. The units or tablets are then frozen and lyophilized in the pack or mould. The resulting units have a very high porosity, which allows rapid water or saliva penetration and very rapid disintegration. Dose handling capability for these systems differs depending on whether the active ingredients are soluble or insoluble drugs, with the dose capability being slightly lower for the former than for some tablet based systems. The units are capable of incorporating a range of taste masked materials and have more rapid disintegration than tablet-based systems.

Compressed tablet-based systems

This system is produced using standard tablet technology by direct compression of excipients. Depending on the method of manufacture, the tablet technologies have different levels of hardness and friability. These results in varying disintegration performance and packaging needs, which can range from standard high density polyethylene (HDPE) bottles or blisters through to more specialists pack designs for product protection, for example, CIMA Labs, PackSolv. The speed of disintegration for fast dissolving tablets compared with a standard tablet is achieved by formulating using water soluble excipients, or superdisintegrate or effervescent components, to allow rapid penetration of water into the core of the tablet. The one exception to this approach for tablets is Biovail Fuisz Technology. It uses the proprietary Shearform system to produce drug loaded candy floss, which is then used for tableting with other excipients. These systems can theoretically accommodate relatively high doses of drug material, including taste masked coated particles. The potential disadvantage is that they take longer to disintegrate than the thin film or lyophilized dosage forms. The loose compression tablet approach has increasingly been used by some technology houses, branded companies, and generic pharmaceutical companies, for inhouse development of line extension and generic fast dissolving dosage forms.

OTF

Oral films, also called oral wafers in the related literature, are a group of flat films which are administered into the oral cavity. Although oral film systems, the third class, have been in existence for a number of years, they have recently become the new area of interest in fast-dissolve pharmaceutical drug delivery. Dissolvable OTF or OS have evolved over the past few years from confection and oral care markets in the form of breath strips and become a novel and widely accepted form by consumers for delivering vitamins and personal care products. Companies with experience in the formulation of polymer coatings containing active pharmaceutical ingredients (APIs) for transdermal drug delivery capitalized on the opportunity to transition this technology to OTF formats. Today, OTF are a proven and accepted technology for systemic delivery of APIs for over-the-counter (OTC) medications and are in the early- to mid-development stages for prescription drugs.

SPECIAL FEATURES OF FAST DISSOLVING FILMS

  • Film should be thin and elegant.

  • Available in various size and shapes.

  • Unobstructive.

  • It should adhere to the oral cavity easily.

  • Should processes fast disintegration without water.

  • Rapid release.

ADVANTAGES OF FAST DISSOLVING FILMS

  • Convenient dosing.

  • No water needed.

  • No risk of chocking.

  • Taste masking.

  • Enhanced stability.

  • Improved patient compliance.

  • The drug enters the systemic circulation with reduced hepatic first pass effect.

  • Site specific and local action.

  • Availability of large surface area that leads to rapid disintegration and dissolution within oral cavity.

  • Dose accuracy in comparison to syrup.

DISADVANTAGE OF OS

  • The disadvantage of OS is that high dose cannot be incorporated into the strip. The dose should be between 1-30 mg.

  • There remain a number of technical limitations with use of film strips; the thickness while casting the film. Glass Petri plates cannot be used for casting.

  • The other technical challenge with these dosage forms is achieving dose uniformity.

  • Packaging of films requires special equipments and it is difficult to pack.

IDEAL CHARACTERISTICS OF A SUITABLE DRUG CANDIDATE

  • The drug should have pleasant taste.

  • The drug to be incorporated should have low dose up to 40 mg.

  • The drug should have smaller and moderate molecular weight.

  • The drug should have good stability and solubility in water as well as saliva.