Spray film-forming systems (SFFSs) provide great potential for the treatment of various types of wounds. Such systems afford to prolong the action of active substances, to prevent cross-contamination, and to ensure accelerated wound healing. Spray films are known since the mid-20th century, and nowadays they are widely used to treat minor skin injuries, but numerous clinical cases describe their successful use in the treatment of burns, wounds, bedsores, etc. The current level of polymer development and composite synthesis has greatly expanded the possibilities of creating compositions of spray film-forming systems. Scattered information and lack of standardization of such delivery systems creates difficulties for pharmaceutical development. This review highlights most of the existing requirements and suggestions from studies to standardize the characteristics of SFFSs and classify them based on scientific sources and regulatory documentation, as well as the position of such systems in the pharmaceutical market. The search and evaluation of known characterization methods and their modifications, as well as the approval of their list (separately for development and for standardization) can potentially increase the research interest in the problem of spray film-forming systems development and contribute to the registration of new drugs and medical devices in this promising dosage form, including with its own pharmacological effect.
Thermosensitive systems based on poloxamer 407 are widely used in targeted drug delivery; however, the stability of the phase transition temperature remains insufficiently studied. This article presents the results of a study on the effect of adding polyethylene glycols (PEG) with different molecular weights and some classical gel-forming polymers on the gelation temperature of thermoreversible compositions based on poloxamer 407 in a long-term experiment. The study showed a positive effect of PEG addition with average molecular weights at concentrations of 1.5–2.0%, as well as gelling agents at a concentration below the critical gelation concentration. The proposed rheological test for studying the samples’ adhesion can give an indirect forecast of the composition adhesive rate. Based on the conducted studies, three experimental binary systems based on poloxamer 407 were selected, with the addition of HPMC 0.5%, sodium alginate 0.5%, and PEG 1500 1.5%. These systems are the most promising for the further development of in situ targeted drug delivery systems.
7 May 2022 in International Journal of Applied Pharmaceutics
Objective: The article presents the results of studying the parameters of in situ systems based on poloxamers. Methods: Natural, synthetic and semi-synthetic polymers were considered as additional gel-forming agents. The above-mentioned agents were cellulose derivatives, as well as rare-cross-linked acrylic polymers, alginic acid salts, and xanthan gum. The gelation temperature was visually recorded during the gradual heating. Mucoadhesion was determined by measuring the separation force of the sample from the mucosal model using pig stomach mucin. The concentration of gel formation was determined using an Ostwald capillary viscometer. Results: During the experiment, 20 samples based on poloxamer 407 18% were examined with the addition of excipients in concentrations of 0.5-2.0%. It was found that the introduction of additional gel-forming agents has a positive effect on the mucoadhesive properties of poloxamer 407. To increase the temperature of gelation of the binary mixture, it is necessary to take into account the own concentration of gelation of the introduced additional polymer, which was confirmed by capillary viscometry. Also, additional viscometric studies revealed the reasons for the absence of a thermoreversible effect in the composition of a poloxamer with xanthan gum and confirmed its use as an excipient in the thermoreversible matrix of poloxamer 407 is impractical. Composition with the best-investigated biopharmaceutical properties-the composition with HEC in a concentration of 0.5% Conclusion: The obtained results can be explained by the fact that when the concentration of additional polymer was exceeded, binary mixtures showed a decrease in the gel formation temperature up to a complete loss of the ability to temperature-dependent sol-gel transition. The choice of an additional gel-forming agent to improve the properties of the system should be based on some specific properties that affect the thermoreversible properties of the system.
7 November 2023 in International Journal of Applied Pharmaceutics
Objective: The objective of this study is to present the main screening parameters for the development of Spray Film-Forming Systems (SFFSs) using the design space. The focus is on characterizing the different phase states of SFFSs during application and establishing appropriate methods for determining the range of parameters. Methods: In this study, various methods were used to determine the range of SFFS parameters. These include contact angle determination, pH test, viscosity measurement, drying rate estimation, spray pattern determination, tensile strength test, and washability. The methods used were evaluated and found to be effective in assessing the quality parameters of liquid concentrates, aerosols, and films of commercially available SFFS samples. Results: Three states (liquid, aerosol, and solid) of commercially available SPSFs were evaluated using the techniques mentioned above. The applicability of the techniques and variability was discussed in comparison with similar studies. The results showed that the mean pH ranged from 5.43±0.02 to 6.63±0.05, the bioadhesion of liquid concentrates was in a narrow range of 4.49±0.52, the highest index of dynamic viscosity was 0.33±0.04, values of the spray pattern ranged from 6.19±1.97 to 17.46±2.72 cm2, bioadhesion values of the films ranged from 3.87 to 4.06 N, average values of film formation time were in the range of 65.55±12.65) s. 3 of the 4 samples had resistance to skin cracking, the tensile load of the commercial SFFS films varied from 2.91±0.3 to 5.11±0.65 N, and the tensile strength from 1.07±0.11 to 1.20±0.3 mPa. All films were not washed off with water. Conclusion: The findings of this study demonstrate the successful application of tested methods in determining the range of parameters for SFFSs. The established values for indicators of liquid concentrates can serve as a basis for the further development of SFFSs. Overall, this research contributes to the understanding and standardization of Spray Film-Forming Systems for wounds, enabling their effective development and application in local skin treatments.