Title:Extraction, Purification, and Development of Sublingual Film (SLIT
Films) Comprising Cockroach Allergen for Treatment of Allergy
Volume: 20
Issue: 6
Author(s): Leishangthem Anita, Venkatesh D. P*, Sajeev Kumar B, Paranjothy Kanni, Chandramouli Ramnarayanan, Roopa Karki, Nagendra Prasad Komarla and Suresh Janadri
Affiliation:
- Pharmaceutics Department Acharya & BM Reddy College of Pharmacy, Bengaluru, India
Keywords:
Sublingual film, allergen, allergy, american cockroach, cockroach extract, sublingual immunotherapy.
Abstract:
Aim: Allergy associated with cockroaches are mostly from the American cockroach (Periplaneta
americana) and German cockroach (Blattella germanica). The effective and safe treatment for
cockroach allergy is Sublingual immunotherapy (SLIT). In this study, SLIT Films containing purified
allergen extract of Periplaneta americana were prepared by solvent casting and were evaluated for
their efficiency in delivery.
Methodology: Cockroach allergen extract was prepared and purified by ultrafiltration and chromatography.
The molecular weight of protein content was identified and estimated by SDS- PAGE and ELISA.
SLIT films were developed by the Quality by Design (QbD) approach and were evaluated for allergen-
excipient compatibility, swelling index, taste, diffusion, in vitro dissolution, local toxicity, and
stability analysis.
Results: Cockroach allergen protein extracts (cut-off 25-71KDa) were identified by SDS-PAGE and
quantified by indirect ELISA and further selected for sublingual film preparation. The indirect ELISA
results show a higher optical density (OD) value compared to crude extract. The weight uniformity and
thickness of the film were between 13-18 mg and 0.04-0.06 mm. The disintegration time was found to
be less than 1 min. The cumulative percentage release was also found to be satisfactory. The local toxicity
study indicated no signs of irritation in the buccal mucosa of rabbits. The optimised F3 film had
uniform thickness, faster disintegration and drug content within pharmacopeial limits. Ex vivo study
revealed better permeability with 90% release of allergen in 7 minutes. The formulation was also stable
at room temperature during the study period.
Conclusion: SLIT Film containing cockroach allergen from Periplaneta americana was successfully
developed and evaluated. SLIT films of cockroach allergen could be more beneficial and convenient
for emergency use in patients when compared to subcutaneous immunotherapy. SLIT films provide
dose accuracy and are a promising alternative for SCIT and SLIT drops and tablets.
