Similar to the solvent
| Condition | Approved Dose | Typical Usage | Notes |
|---|---|---|---|
| Erectile Dysfunction | 20 mg-100 mg | Administer 30-60 min before activity | Dose depends on severity |
| Pulmonary Arterial Hypertension | 5 mg-20 mg | Usually 3 times daily | Under medical supervision |
| Raynaud's Phenomenon | Off-label | 20 mg before episodes | Not officially approved |
casting method, the electrospinning technique
There are several patented technologies developed including Zydis [Citation38], Quick-dis, Oraquick, Durasolv [Citation39], Shearform [Citation40], Flashtab [Citation41], Flashdose [Citation42], Wowtab [Citation43], Nanocrystal [Citation44], Lyoc [Citation45], Ziplet, Pharmaburst [Citation46], and Frosta [Citation47] technologies that utilize the varied conventional and innovative techniques to manufacture mouth-dissolving tablets [Citation32,Citation33,Citation48]. [Citation32] have discussed elaborately on the manufacturing methodologies leveraged in the production of orodispersible tablets through patented technologies. Further description is outside the scope of this article. Over the years, manufacturing of ODFs has evolved from technologies that were used to produce transdermal patches, namely, hot-melt extrusion, perforated film technology, and solvent casting technique [Citation6,Citation33,Citation49]. These ever-emerging sophisticated manufacturing methods have succeeded in the production of dosage forms that are stable, thin, and flexible with considerable mechanical and tensile strength.
In addition, they can be fabricated in varied sizes and shapes, offering optimal transport and storage options [Citation8]. highlights the standard composition and critical quality attribute of ODFs. During preparation of orally disintegrating formulations, it’s important to conisder numerous parameters such as tensile strength, pH, thickness and the selection of an appropriate polymer blend suitable for drug release. The crucial step in the formulation of orodispersible film depends on judicial selection of polymers and polymer blends and the appropriate method of preparation [Citation50]. The primary methods used in the formulation of ODFs include the solvent casting technique, semisolid casting, solid dispersion extrusion, electrospinning, hot-melt extrusion (HME), and rolling and the other prominent emerging techniques of 3-dimensional printing (3DP) for personalized dosing [Citation51].
Currently, solvent casting is considered as the most fundamental, commonly employed, feasible and direct technique for manufacturing of oral films. On a laboratory setting and small scale, the ODFs are prepared by mixing different polymers and other basic ingredients, which are dissolved in an appropriate solvent to form a homogenous solution. This resultant solution is subsequently casted onto a petri dish or a substrate and kept overnight for drying in oven that aids in the formation of a thin film. However, choosing a suitable temperature for drying is critical during the preparation of ODFs, as higher temperatures can cause mechanical instability, shrinking of films, and API degradation. Apparently during the fabricating process of ODFs on a large industrial scale, the solvent casting method consists of several steps encompassing definite dispensing of the API, sildenafil pick up excipients, and FDA-approved class III solvents. employs organic solvents, which
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pose undesired environmental issues [Citation2,Citation33].
| Aspect | Oral Solution | Tablets |
|---|---|---|
| Onset of action | Faster due to quicker absorption | Slightly slower |
| Ease of dose adjustment | Easy to modify dose in small increments | Fixed doses |
| Swallowing difficulties | Easier for children and elderly | Requires swallowing whole |
| Taste masking | Usually palatable with flavors | No taste masking needed |
| Storage and stability | Sensitive to temperature and light | Generally more stable |
(2023) most recently evaluated the feasibility
These ingredients are mixed in a low or high-shear mixer to form homogenous dispersion under thermostatic control. Enough caution is ensued while introducing encapsulated drug actives in high-shear mixers, as it may cause peeling off of the encapsulating material. The resultant slurry is subjected to solvent evaporation at predetermined temperature in a hot-air oven. This mixture is later smeared onto a liner employing a knife-over-roll coater, which is supplied with an accurate pin gauge. Subsequently, the dried laminates are rolled onto the master rolls, nicked into discrete dose units based on the specific dimensions, and packed within tamper-proof pouches or sachets.
Nevertheless, the solvent casting offers a number of benefits including excellent physical qualities, simple and reduced production costs, and uniformity of the thickness of the film [Citation52]. The large-scale production of ODFs using this technique must consider the crucial challenges, which may heighten with the scale of production. These are some of the challenges that are not limited to equipment adaptation; preservation of coveted film characteristics; maintaining uniformity and homogeneity of the film; avoidance of inconsistencies during mixing and casting processes; ensuring complete drying to prevent changes in the membrane structure, drug dissolution, and release pattern; preserving the integrity of film without any defects such as cracking or irregular thickness; prevention of entrapment of air bubbles; film shriveling; and rippling effect. An optimum temperature needs to be maintained as well because the presence of humidity may induce undesired polymorphic transitions [Citation2,Citation5,Citation33]. These challenges demand proper planning and optimization of processes, maintenance of optimum temperature and humidity, and conscientious batch-to-batch consistency and conform to regulatory standards in order to deliver high-quality ODFs during the industrial scale-up [Citation5,Citation52] ().
(2014) prepared, characterized, and conducted in vitro evaluation of a polyvinyl alcohol/sodium alginate-based orodispersible film containing sildenafil citrate. They recommended that this simple solvent casting method might serve as an alternative to conventional sildenafil tablets for the treatment of erectile dysfunction [Citation53]. Owing to the several advantages, this technique is successfully employed in the development of sublingual films for various generics and products, including everolimus ODF for the treatment of advanced cancer [Citation54], pregabalin for the treatment of epilepsy [Citation55], and aripiprazole for the treatment of several mental disorders [Citation56]. This method is also known as “electrostatic spinning” and utilizes solvents for the fabrication of ODFs, which is featured by a high-porous inner structure [Citation7]. In this technique, the spherical shaped polymer solution droplets are transposed to conical shape, which results in the formation of nanosized fiber filaments. of electrospinning technique in the manufacturing
These stable granules are cooled and allowed to solidify and compressed into tablets. This method does not use water or organic solvents during manufacturing, which makes them better than conventional granulation and can be a beneficial method to prolong the dissolution rate of poorly water-soluble drugs [Citation32]. The preparation process is faster and has less energy consumption than wet granulation [Citation23,Citation33,Citation34]. This process is also called as “sugar floss” or “candy floss technique” as it utilizes a unique spinning mechanism to produce floss-like crystalline structure, which appears similar to a cotton candy [Citation32,Citation35]. In this technique, a matrix is built using polysaccharides or saccharides and with concurrent actions of flash melting and spinning.
This causes the formation of floss matrix, which is either partially or entirely recrystallized to enhance the flow properties and compressibility. The floss matrix is further pulverized, mixed and blended with a mixture of API and excipients, and ultimately compressed into ODTs. This process is beneficial for accommodating excessive doses of APIs. ODTs prepared using this method exhibit excellent mechanical strength compared to other techniques. Since the method uses high temperatures, thermolabile drugs cannot be formulated as ODT through this approach [Citation23,Citation36,Citation37].
This recently developed nanomelt technology produces nanocrystals by reducing the particle size of drugs to nanosize using a wet milling process. The drug nanocrystals are the combined with stabilizers, which, by adsorbing onto their surfaces, prevent them from clumping and aid integrate them in ODTs. This technique is best suitable for those drugs that are marginally or poorly water-soluble and have wide dose range (up to 200 mg of drug per unit). The ODTs have considerably fast nanoparticle dissolution, increased absorption, and improved bioavailability. This lowers dose requirements and cost-effectiveness compared to other conventional technologies, which makes it a popular technique [Citation28,Citation32]. of pullulan-based sildenafil ODFs intended for
treating pediatric patients with pulmonary hypertension.
Interestingly, the electrospun products in
| Drug Class | Potential Effect | Clinical Note |
|---|---|---|
| Nitrates | Severe hypotension | Absolute contraindication |
| Alpha-blockers | Increased risk of hypotension | Use with caution |
| CYP3A4 inhibitors (e.g., ketoconazole) | Increased sildenafil levels | Dose adjustment needed |
| Other vasodilators | Enhanced vasodilatory effects | Monitor blood pressure |
the ODFs showed faster disintegration process
(i.e., occurring within few seconds) and
These electrospin nanofibers offer distinct properties including increased surface area-to-volume ratio and along with other mechanical attributes. This facilitates the customization of ODFs to demonstrate special functions like controlled release, tissue engineering, filtration, and other purposes with respect to energy storage. This solvent-based technology requires a specialized electrospinning device. The solvent formulation is pumped through a metallic needle at controlled rate. A high-voltage electric current is passed through this needle that ejects out as a dispersion jet/spinneret and collects on an opposite-charged collector.
The API can be introduced initially or at the end of the spinning process [Citation57,Citation58]. The factors such as polymer concentration, shear force, viscosity of the polymer solution, strength of the electric field applied, and spinning distance must be optimized for obtaining the appropriate diameter and structure of nanofibers [Citation59]. These ODFs made up of nanofibers can be designed and fabricated to different shapes and dimensions. This nanofiber-fabricated ODFs enable its usage in personalized medicine or targeted therapies that eventually can be tailored to patient-specific needs. These films also offer excellent benefits including remarkable mechanical robustness, flexibility, dose precision, controlled release of drugs at a preset rate, enhanced bioavailability, and faster Tmax (time taken to reach the maximum concentration). were very well compliant with Ph.