Patent AU-2021103981-A4 (AU)
Title: Method and Process for the Developments of Sago Starch Buccal Film for Buccal Delivery of Antidiabetic Drug
Inventor: MALVIYA RISHABHA
IPC: A61K47/38
Filed: 2021-07-08
Granted: 2022-04-07
Abstract: The oral route is the most appropriate among the different route of administration. Although, 
a major disadvantage of oral drugs, is that they are vulnerable to degradation in GI tract 
or hepatic first metabolism. The delivery of drugs via mucosal surfaces such as the nasal, 
rectal, oral and vaginal surfaces is therefore a solution. Among the various sites suitable for 
the delivery of mucoadhesive medication is the buccal mucosa, because of its high 
accessibility, robust epithelium, rapid and easy drug product removal when needed, better 
absorption of the drug, decreased hepatic metabolism and improved compliance with the 
patient. Thus, in this innovation, step have taken to design buccal mucoadhesive films to 
overcome the disadvantage of existing tablets. Diabetes is a multimetabolic disorder 
characterised by high blood sugar levels due to insulin release deficiencies or insulin 
performance or both. Glimepiride (GMD) is an effective and enduring diabetic hypoglycemic 
medication. The disadvantage of the use of GMD as oral dosage form is due to the low water 
solubility and delayed dissolution, resulting in low oral bioavailability. This work contributes 
to develop mucoadhesive buccal films for controlled delivery of the drug for a prolonged 
period of time to manage diabetes. In this invention gelatinised sago starch is used to prepare 
buccal films for controlled drug delivery. Solvent casting method is used to formulate buccal 
films. The gelatinized sago starch powder was evaluated for different parameters like bulk 
and tapped density, Carr's index, swellability, viscosity, surface tension etc. Six different film 
formulations were prepared containing 20mg of Glimepiride by solvent casting method.  
Buccal films were characterized by a wide range of variables such as surface pH, physical 
appearance, weight uniformity, thickness, folding endurance, swelling index, drug- excipients 
interaction study, uniformity of drug content and in vitro release studies. The drug content of 
films was in the range of 93% to 98.43%. Batch F2 was found to have maximum drug 
content. All the films possessed a good tensile strength. Percentage drug release of all the 
batches was in range from 93.87 to 97.12. Batch Fl and F2 showed maximum release of 
97.02 % while F6 batch shows minimum release of 93.87 %. More than 50 % of the drug is 
released after a period of 45 mins in all the 6 batches. The results suggest that the prepared 
films show an excellent drug release of more than 93 % from all the batches. It was inferred 
from the findings that the sago starch may be a highly beneficial platform for oral drug 
administration. Various concentration of sago starch can regulate the time of drug 
release behaviour.  
9
Weighed the ingredients accurately 
Polymer (starch) is dispersed in 20 ml 
Stirred continuously fr half an hour at 55°C 
HPMC was add to the mixture 
Added drug and glycrol in starch solution 
Prepared solution is casted in a petri dish 
dried for a tempe ature below 400 C 
dried films were cut in desired sizeand kept under ambient condition 
Figure 1: Flow chart of formulation of Buccal films 
120 
100 
80 
60 -- -F 
w F2 
a 40 -A-F3 
20 
0 I 
0 50 100 150 200 250 300 350 400 
Time (min) 
Figure 2: Comparative study of % drug release of buccal film