Name: Pawan Dhamala Soluble Ocular Drug Insert(SODI) M.Pharmacy , Pharmaceutics RR College of Pharmacy, Bangalore India

1. 26-05-2022 © R R INSTITUTIONS , BANGALORE 1
SOLUBLE OCULAR DRUG INSERT
RR COLLEGE OF PHARMACY
SUBMITTED BY: SUBMITTED TO:
PAWAN DHAMALA Dr. A. GEETHA LAKSHMI
1ST SEM , M.PHARMACY PROF. & HOD
DEPARTMENT OF PHARMACEUTICS

2. 26-05-2022 © R R INSTITUTIONS , BANGALORE
2
• Introduction
• Mechanism of Drug Release from SODI
• Video showing how to insert SODI in the eye
• Method of preparation of SODI
• Physiochemical Evaluation of SODI
• Advantages of SODI
• Disadvantages of SODI
• Uses
• References

3. • Soluble ocular drug insert (SODI) is a small oval wafer, which was
developed by soviet scientists for cosmonauts who could not use eye
drops in weightless conditions.
• The SODIs are the result of a vast collaborative effort between
eminent Russian chemists and ophthalmologists, and led eventually (in
1976) to the development of a new soluble copolymer of acrylamide,
N-vinylpyrrolidone and ethyl acrylate (ratio 0.25: 0.25: 0.5),
designated ABE.
• A comparison of medicated eye films prepared with different
polymers, showed that ABE produced the highest concentration of
drugs in rabbit ocular tissues.
26-05-2022 © R R INSTITUTIONS , BANGALORE 3

4. • After large-scale preclinical and clinical testing, the ABE copolymer was
used for the industrial manufacture of the SODI in the form of sterile thin
films of oval shape (9 x 4.5 mm, thickness 0.35 mm), weighing 15-16 mg,
and color-coded for different drugs (over 20 common ophthalmic drugs, or
drug combinations).
• After introduction into the upper conjunctival sac, a SODI softens in l0-15
s, conforming to the shape of the eyeball.
• In the next l0-15 min the film turns into a polymer clot, which gradually
dissolves within 1 h while releasing the drug. The sensation of an
‘extraneous body’ in the eye disappears in 5-15 min.
26-05-2022 © R R INSTITUTIONS , BANGALORE 4

5. • They are further categorized:
I. Based on natural polymers, for example, collagen.
II. Based on synthetic or semi-synthetic polymers.
Natural polymers
The first type of soluble inserts is based on natural polymer.
Natural polymer used to produce soluble ophthalmic inserts is
preferably collagen.
The therapeutic agent is preferably absorbed by soaking the insert in a
solution containing the drug, drying, and re-hydrating it before use on
the eye.
The amount of drug loaded will depend on the amount of binding agent
present, the concentration of the drug solution into which the composite
is soaked as well as the duration of the soaking. As the collagen
dissolves, the drug is gradually released from the interstics between the
collagen molecules.
26-05-2022 © R R INSTITUTIONS , BANGALORE 5

6. Synthetic and semi-synthetic polymer
The second type of soluble insert is usually based on semi-synthetic
polymers (e.g., cellulose derivatives) or on synthetic polymers such as
polyvinyl alcohol.
A decrease of release rate can be obtained by using Eudragit, a
polymer normally used for enteric coating, as a coating agent of the
insert.
 It have observed in rabbits that Eudragit coated inserts containing
pilocarpine induced a miotic effect of a longer duration, compared to
the corresponding uncoated ones.
Ethyl cellulose, a hydrophobic polymer, can be used to decrease the
deformation of the insert and thus to prevent blurred vision.
26-05-2022 © R R INSTITUTIONS , BANGALORE 6

7. • The mechanism of controlled drug release into the eye from SODI are
as follows: A. Diffusion, B. Osmosis, C. Bio-erosion
A. Diffusion
In the Diffusion mechanism, the drug is released continuously at a
controlled rate through the membrane into the tear fluid.
The release of drug can take place via diffusion through the pores.
26-05-2022 © R R INSTITUTIONS , BANGALORE 7

8. B. Osmosis
In the Osmosis mechanism, the insert comprises a transverse
impermeable elastic membrane dividing the interior of the insert into a
first compartment and a second compartment; the first compartment is
bounded by a semi-permeable membrane and the impermeable elastic
membrane, and the second compartment is bounded by an
impermeable material and the elastic membrane.
The first compartment contains a solute which cannot pass through the
semi-permeable membrane and the second compartment provides a
reservoir for the drug which again is in liquid or gel form.
When the insert is placed in the aqueous environment of the eye,
water diffuses into the first compartment and stretches the elastic
membrane to expand the first compartment and contract the second
compartment so that the drug is forced through the drug release
aperture.
26-05-2022 © R R INSTITUTIONS , BANGALORE 8

9. C. Bio-erosion
In the Bioerosion mechanism,the configuration of the body of the
insert is constituted from a matrix of bioerodible material in which the
drug is dispersed.
Contact of the insert with tear fluid results in controlled sustained
release of the drug by bioerosion of the matrix.
26-05-2022 © R R INSTITUTIONS , BANGALORE 9

10. 26-05-2022 © R R INSTITUTIONS , BANGALORE 10

11. • Drug reservoir films containing different concentrations of the polymer and
gelatin were prepared by solvent casting method using mercury as a
substrate.
• Water was used as a casting solvent to prepare the solution of polymer and
drug while glycerin was employed as a plasticizer.
• Glycerin was used in concentration of 70% w/w on the basis of weight of
dry polymer.
• Drug reservoir film containing 50 mg of the drug was prepared using a ring
of 4 cm diameter having 3 mL capacity.
26-05-2022 © R R INSTITUTIONS , BANGALORE 11

12. • After drying at room temperature for 24 h, circular rings of 8 mm
diameter each containing 2 mg of the drug were taken out.
• Rate controlling membrane was prepared using three different
concentration of ethyl cellulose and employing dibutyl phthalate as a
plasticizer.
• Dibutyl phthalate was used in the concentration of 30% w/w based on
the weight of dry polymer.
• Films were prepared by solvent casting method using methanol as a
casting solvent.
• After drying at room temperature circular rings of 10 mm diameter
were cut and used to seal both the sides of the drug reservoir to control
release from the periphery .
26-05-2022 © R R INSTITUTIONS , BANGALORE 12

13. • The prepared SODI were evaluated for thickness, weight variation,
drug content, percent moisture loss, and percent moisture absorption.
1. Uniformity of Thickness: Insert thickness was measured at three
different points using Micrometer screw gauge and mean film
thickness was noted.
2. Uniformity of Weight: From each batch, three inserts were taken out
and weighed individually using digital balance .The mean weight of
insert was noted.
3. Drug Content Uniformity: To check the drug content uniformity,
three inserts were taken out from each film and drug content
determined using the procedure of IP.
26-05-2022 © R R INSTITUTIONS , BANGALORE 13

14. 4. Percentage Moisture Absorption: Percentage moisture absorption test was
carried out to check the integrity of the inserts. Individual inserts were
weighed and placed in a dessicator maintained at high relative humidity
using an excess amount of salt in solution. After three days the inserts were
taken out and reweighed. The percentage moisture absorption was calculated
using the formula.
5. Percentage Moisture Loss: Percentage moisture loss was carried out to
check the integrity of the film at dry conditions. Three inserts from each was
taken for study. Inserts were weighed individually and kept in a desiccator
containing anhydrous calcium chloride. After three days, inserts were taken
out and reweighed. Percentage moisture loss was calculated using the
formula.
26-05-2022 © R R INSTITUTIONS , BANGALORE 14

15. • Reduced role of the physician , since the form is dissolved by total or
partial solubilization and there is no need to surgically remove the insert
once the drug has been released.
• Increase the contact time between the preparation and the conjunctival
tissue.
• Increased ocular residence, hence, prolonged drug activity and higher
bioavailability.
• Release of drugs at a slow, constant rate.
• Accurate dosing.
• Reduction of systemic absorption.
• Better patient compliance, due to reduced frequency of administration and
less incidence of visual and systemic side-effects.
26-05-2022 © R R INSTITUTIONS , BANGALORE 15

16. • Increased shelf life with respect to aqueous solutions.
• Exclusion of preservatives, thus reducing the risk of sensitivity
reactions.
• A major disadvantage of soluble ocular drug inserts resides in their
'solidity', that is, they are felt by the (often oversensitive) patients as an
extraneous body in the eye.
• Difficulty in placement.
• Their movement around the eye, in rare instances, the simple removal
is made more difficult by unwanted migration of the insert to the upper
fornix.
26-05-2022 © R R INSTITUTIONS , BANGALORE 16

17. • In the treatment of Dry eye syndrome is a multifactorial disease of the
tears and ocular surface that results in symptoms of discomfort,
burning, itching, foreign body sensation, dryness, pain.
• Photophobia, hyperemia, visual disturbance, and tear film instability,
with potential damage to the ocular surface.
26-05-2022 © R R INSTITUTIONS , BANGALORE 17

18. • The concept of ocular inserts as drug delivery systems: An overview
by Deivasigamani Karthikeyan, Mithun Bhowmick, Vijay Prakesh
Pandey1 , Jothivel Nandhakumar, Singaravel Sengottuvelu, Sandeep
Sonkar, Thangavel Sivakumar
• Design and Evaluation of Soluble Ocular Drug Insert for Controlled
Release of Ciprofloxacin Hydrochloride by A. S. Mundada and B. K.
Shrikhande
• Ocular inserts — Advancement in therapy of eye diseases by Anita
Kumari, Pramod K. Sharma, Vipin K. Garg, Garima Garg
• Novel Drug Delivery system by NK.Jain
• www.google.com
26-05-2022 © R R INSTITUTIONS , BANGALORE 18

19. 26-05-2022 © R R INSTITUTIONS , BANGALORE 19