Development of Fast Dissolving Oral Films Containing Vitamin B6 for Nausea and Vomiting of Pregnancy (NVP)
The aim of this study was to formulate and evaluate the oral fast-dissolving film of Vitamin B6 for the effective management of motion sickness and vomiting during pregnancy. Fast-dissolving films were prepared by the solvent-casting method using different polymers, HPMC-15 and Pullulan, along with Propylene glycol as a plasticizer. The Fourier-transform infrared study for the drug-polymer interaction was carried out. Evaluation of physical parameters such as physical appearance, surface texture, uniformity of weight, uniformity of strip thickness, surface pH, folding endurance, uniformity of drug content and percentage of moisture absorption were performed. Kinetic data analysis for the release study and the stability study were also performed. Results of uniformity of weight, thickness, folding endurance, surface pH, percentage drug content, tensile strength and percentage elongation of all the films were found to be satisfactory. The Fourier-transform infrared study indicated that there was no interaction between the drug and the polymers. The in-vitro drug release study showed that a better rate of drug release was achieved by formulations F4 and F8 compared with other formulations. The stability study did not show any significant difference in the external appearance, the drug content and the in-vitro drug release. In conclusion present study suggested that fast dissolving films has a better ability to cross the sublingual barrier at a faster rate, and hence the delivery system was found to be promising as it has the potential of overcoming the drawbacks associated with tablet formulations available in the market presently.
Keywords: Fast-dissolving film, Vitamin B6, HPMC-15, Pullulan gum, Mango peel pectin, Crospovidone, solvent casting
2. Liang CA, Chen HL, Fast dissolving intraoral drug delivery systems. Expert Opin Ther Pate. 2001;11: 981-6.
3. Goel H, Rai P, Rana V, Tiwary KA. Orally disintegration systems: Innovations in formulation and technology. Recent Pate Drug Deliv Form. 2008; 2:258-74.
4. Ali MS, Vijendar C, Kumar SD, Krishnaveni J. Formulation and evaluation of fast dissolving oral films of diazepam. J Pharmacovigilence. 2016; 4(3):1-5.
5. Koradia DK, Sidhdhapara TP, Sheth RN. Preparation and optimization of fast dissolving film of naratriptan hydrochloride. Recent Patents Drug Del Form. 2017; 11(2):124-31.
6. Narwal S, Saini V. Formulation, development and evaluation of fast disintegrating thin film of esomeprazole magnesium trihydrate. Am J Pharm Tech Res. 2016; 6(4):519-40.
7. Shah C, Rathod K, Sanghvi K. Formulation development and optimization of rapid dissolving film of Olanzapine. Int J Pharm Res Bio-Sci. 2014; 3(2):555-69.
8. Saini S, Nanda A, Dhari J. Formulation, development and evaluation of oral fast dissolving anti-allergic film of levocetrizine dihydrochloride. Pharm Sci Res. 2011; 3(7):1322-5.
9. Sharma YR. Elementary organic spectroscopy, principles and chemical application. 1st ed. S. Chand publication; 2001:p.81-82.
10. Ahmed MG, Narayana CR, Harish NM, Prabhu P, Roopesh PT. Polymeric strips containing sparfloxacin for the long term treatment of periodontitis. Int J Pharm Res. 2008:48-53
11. Kanakadurga ND, Rani AP, Mrudula SB. Formulation and evaluation of oral disintegrating tablets of Montelukast sodium: effect of functionality of superdisintegrants. J Pharma Res. 2010; 3(4):803-8.
12. Bhaskaran S. Industrial pharmacy. 1st ed. New Delhi. Birla Publications, Pvt. Ltd; 2010. p. 46-69.
13. ICH Q1A (R2) Stability testing guidelines: Stability testing of new drug substances and products. [Online]. [Cited 20017 nov 10]; available form: URL:
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
Authors who publish with this journal agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0). that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).