Formulation and evaluation of bimatoprost nanoemulgel for treatment of glaucoma
1. Formulation and evaluation of bimatoprost
nanoemulgel for treatment of Glaucoma
Supervisor:
Prof(Dr.) R.B.Sharma
Principal
Himalayan Institute of Pharmacy,
Kala Amb Dist. Sirmaur (H.P.)173030
Submitted By
Hitesh Thakur
(M. Pharmacy 3rd sem.)
Roll. No. 20012817005
Department of Pharmaceutics
Himalayan institute of Pharmacy
Kala Amb, Dist. Sirmaur (H.P)
(Affiliated to HPTU. Approved By: PCI, AICTE, Recognized by the UGC Under 2(f) of UGC Act,1956)
3. Introduction
● Glaucoma: Glaucoma is a set of eye illnesses that damage the optic nerve, a nerve
in the back of the eye that can cause vision loss and blindness. Increased pressure
damages the optic nerve when fluid builds up as a result of poor drainage or
overproduction of fluid. If left untreated, glaucoma can cause vision loss. Glaucoma
vision loss is irreversible once it has occurred.
● Symptoms:
Glaucoma signs and symptoms vary depending on the kind and stage of the disease.
Consider the following scenario:
❖ Glaucoma with an open angle:
● Blind patches in your peripheral (side) or central vision, often in both eyes
● Advanced phases of tunnel vision
❖ Glaucoma with acute angle closure:
● Headache that is severe.
● Pain in the eyes.
● Vomiting and nausea.
● Vision is hazy.
● Lights with halo effects.
● Redness in the eyes.
4. Emulgel
● Definition: When Gel and emulsion are used in combinated from the dosage form
are referred to ‘emulgel’.
▪ The use of transparent gel has expanded both in cosmetics and in pharmaceutical
preparations.
▪ Both o/w and w/o emulsions are used as vehicles to deliver various drugs to the
skin.
Emulsion + Gel = Emulgel
6. Nano Emulgel
• Nanoemulgel is a drug delivery method that is currently being researched and
developed for a variety of ocular formulations in both pharmaceutical and
cosmeceutical purposes. Nanoemulgel is made out of a water-in-oil or oil-in-water
emulsion mixed into a gel base. Nanoemulgel is an emulsion-based gel formulation in
which nanosized emulsion globules are created using high or low energy processes
and then transformed to nanoemulgel by adding a suitable gelling agent.
Advantages:
• Better stability.
• Beter drug loading capacity
• Controlled release, medication can be terminated when needed.
7. Bimatoprost
● Bimatoprost is a medicine that is used to treat high pressure inside the eye, such as
glaucoma. It is offered under the trade names Lumigan and others. It's used to treat
open angle glaucoma when other treatments aren't working. It can also be used to
make eyelashes grow longer. It is used as an eye drop and effects generally occur
within four hours. Bimatoprost belongs to the prostaglandin analogues class of
drugs.
Uses:
● Medical:
Bimatoprost is a beta blocker that is used to treat open-angle glaucoma and ocular
hypertension in adults. It can be used alone or in combination with a beta blocker
like timolol.
● Cosmetic:
Small or undeveloped eyelashes can be treated with bimatoprost. The medical
word for this is hypotrichosis treatment; nevertheless, the FDA permission is only
for cosmetic purposes.
8. • Side Effects:
Other prostaglandin analogues used in the eye have similar side effects. Conjunctival
hyperemia, which affects more than 10% of patients, is the most prevalent. Blurred
vision, eye and eyelid redness, eye burning or other irritation, and a permanent
darkening of the iris to brown are some of the other side effects. Headache and nausea
are rare side effects (affecting less than 1% of people). Some of the negative effects are
unique to the cosmetic formulation, which is applied to the skin at the base of the
eyelash instead of being injected into the eye. If the one-time applicators are reused,
infections can occur, as well as darkening of the eyelid or the area behind the eye.
9. Aim and Objective
● The study's major goal is to develop a bimatoprost emulgel of bimatoprost, a lipid-
lowering drug, in order to address bioavailability issues, reduce dose-dependent
side effects, and reduce administration frequency.
● The goal of this study is to increase the solubility and dissolution rate of the model
medication bimatoprost in glaucoma patients. Bimatoprost is a drug that is used to
treat glaucoma, or high pressure inside the eye. Lumigan and other trade names
are used to market it. When other therapies don't work, it's used to treat open angle
glaucoma. It can also be used to lengthen the lashes. It's used as an eye drop, and
the benefits usually last four hours. The prostaglandin analogues class of drugs
includes bimatoprost.
Primary objectives included in this study are:
To develop bimatoprost emulgel.
To find out is the drug compatible with
excipients in emulgel for glaucoma patients.
Characterization of the bimatoprost including
various physicochemical characterization
To improve the patient compliance
10. Plan Of Work
This work will be executed as follow:
Collection of various materials to be used in experiment.
To study Preformulation parameters of drug and excipients.
To check the compatibility among drug and excipients by using FTIR., X-ray
Diffraction and Differential scanning calorimetry
To formulate the bimatoprost emulgel.
Characterization of the bimatoprost emulgel. including physicochemical
characterization i.e. Physical Examination, Spreadability, pH determination, Rheology
studies, Drug content, Globule size and distribution in emulgel, Centrifugation study,
Swelling Index.
To perform in vitro drug release study and release kinetics.
To study the stability kinetics
11. Material And Methods
● Sources of data: Official Pharmacopoeia, standard books, pharmaceutics databases,
internet, research and review articles etc.
● Drug: Bimatoprost
● Excipients to be use: Carboxymethylcellulose Sodium (CMC).
● Methodology to be used for preparation of Bimatoprost emulgel:
● The methodology to be used in this research will be as:
● To obtain drug and material that will be used in research.
● To study preformulation parameters of drug and excipients.
● To check the compatibility among drug and excipients by using FTIR, X-ray Diffraction
and Differential scanning calorimetry.
● To formulate the Bimatoprost nano emulgel of bimatoprost by a oil in water emulsion
mixed into gel method.
● Characterization of the Bimatoprost emulgel including physicochemical characterization
i.e. Physical Examination, Spreadability, pH determination, Rheology studies, Drug
content, Globule size and distribution in emulgel, Centrifugation study, Swelling Index.
● To perform in vitro drug release study and release kinetics.
● To study the stability kinetics.
● Evaluation of Proniosomes
● Bimatoprost emulgel will be evaluated by suitable methods given in Pharmacopoeia,
Research and review articles etc.
12. References
● Jaswal P, Sharma RB, Agarwal S (2016). “Recent trends in ocular drug delivery system”. Int
J Pharm Sci Rev Res. 38: 119-24.
● Medeiros FA, Walters TR, Kolko M, Coote M, Bejanian M, Goodkin ML,Guo Q, Zhang J,
Robinson MR, Weinreb RN (2020). “Study Group, Phase 3, Randomized, 20-Month Study
of Bimatoprost Implant in Open-Angle Glaucoma and Ocular Hypertension (ARTEMIS 1)”.
Ophthalmology.
● Shaoqing He, Dorota L. Stankowska, Dorette Z. Ellis, Raghu R. Krishnamoorthy, Thomas
Yorio (2017). “Targets of Neuroprotection in Glaucoma”. J Ocular Pharmacol Therap.
00(00).
● D Dingra, A Bhandari, RB Sharma, Gupta R, Gupta S (2010). “Enhancement of dissolution
rate of slightly soluble drug Clomiphene Citrate by solid dispersion”. Int. J. Chem Tech Res,
2010, 2: 1691-1697.
● Sharma RB, Ranawat MS, Bhandari A, Puri D (2013). “The Study of Guar Gum and Starch
on Disintegration Time and Drug Release of Fast Dissolving Tablet in Rabbit Using Single
Dose Randomized Parallel Design Method”. Jordan J Pharm Sci. 6(3): 280-291.
● R Sharma, MS Ranawat, B Sayra, A Bhandar, CS Chouhan. “Statistical screening of starch
paste and guar gum on hardness and disintegration time of fast dissolving tablet”. Int J
Pharmacy & Pharm Sci. 1-7.
● Shivaraj B. Katageri, Sharma RB (2016). “Development and Optimization of Self-
Nanoemulsifying tablet dosage form of Nateglinide using Box–Behnken design”. J Pharm
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● Sharma RB, Arora V, Arora S, Kapila A, Sharma R. “The effect of biomaterials of
croscarmellose sodium and Eudragit S-100 as model polymers on colon targeted drug
release in different dosage forms”.