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Daftar Lengkap Formulasi Tetes Mata dan Telinga dalam Industri Farmasi

August 21, 2026

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Daftar Isi

Pengantar Tetes Mata dan Telinga
formulasi“>Daftar Formulasi Ophtalmik dan Telinga
Kategori Formulasi
Kesimpulan

1. Pengantar Tetes Mata dan Telinga

Formulasi ophtalmik dan otikal merupakan salah satu kategori sediaan farmasi yang sangat penting dalam terapi penyakit mata dan telinga. Sediaan ini dirancang khusus untuk memberikan efek terapeutik lokal pada organ target dengan konsentrasi yang tepat dan efek sistemik minimal. Pemahaman mendalam mengenai komposisi, stabilitas, dan cara kerja masing-masing formulasi sangat krusial bagi praktisi farmasi dalam memilih sediaan yang sesuai untuk pasien.

Dalam industri farmasi, pengembangan sediaan tetes mata dan telinga memerlukan perhatian khusus terhadap aspek sterilitas, tonisitas, pH, dan penggunaan bahan pengawet yang sesuai. Standar internasional seperti Indian Pharmacopoeia (IP), United States Pharmacopeia (USP), dan European Pharmacopoeia (EP) menjadi acuan dalam memastikan kualitas dan keamanan sediaan. Artikel ini menyajikan daftar lengkap formulasi ophtalmik dan otikal yang umum diproduksi dalam industri farmasi.

2. Daftar Formulasi Ophtalmik dan Telinga

Berikut adalah daftar lengkap formulasi sediaan tetes mata dan telinga yang tersedia dalam industri farmasi.

A. Sediaan Antikolinergik dan Miostatik

No	Nama Generik	Komposisi	Referensi	Klaim	Kekuatan
1	Atropine Sulphate Ophthalmic Solution IP	Atropine Sulphate IP 1% w/v; Phenyl Mercuric Nitrate IP 0.001% w/v; Sterile Aqueous Base q.s	IP	Ophthalmic Solution	1% w/v
2	Atropine Sulphate Ophthalmic Solution IP	Atropine Sulphate IP 0.01% & 0.05% w/v; Stabilised Oxychloro Complex IP 0.005% v/v; Sterile Aqueous Base q.s	IP	Ophthalmic Solution	0.01%, 0.05% w/v

B. Sediaan Antibiotik Ophtalmik

No	Nama Generik	Komposisi	Referensi	Klaim	Kekuatan
3	Amikacin Sulphate HPMC Ophthalmic Solution	Amikacin Sulphate IP 1% & 0.3% w/v; Hydroxypropylmethyl Cellulose IP 0.025% w/v; Phenyl Mercuric Nitrate IP 0.001% w/v; Sterile Aqueous Base q.s	IP	Ophthalmic Solution	1%, 0.3% w/v
5	Amikacin Sulphate Dexamethasone HPMC Ophthalmic Solution	Amikacin Sulphate IP 1% & 0.3% w/v; Dexamethasone Sodium Phosphate IP 0.1% w/v; Hydroxypropylmethyl Cellulose IP 0.025% w/v; Phenyl Mercuric Nitrate IP 0.001% w/v; Sterile Aqueous Base q.s	IP	Ophthalmic Solution	1%, 0.3% w/v
6	Azithromycin Dexamethasone Eye/Ear Drops	Azithromycin IP 10.0 mg; Dexamethasone Sodium Phosphate IP 1.0 mg; Benzalkonium Chloride IP 0.02% w/v; Sterile Suspension Base q.s	IP	Eye/Ear Drops	10mg/1mg
19	Betamethasone Neomycin Eye/Ear Drops	Betamethasone IP 0.1% w/v; Neomycin Sulphate IP 0.5% w/v; Preservative q.s; Sterile Base q.s	IP	Eye/Ear Drops	0.1%, 0.5% w/v
20	Betamethasone Chloramphenicol Eye/Ear Drops	Betamethasone IP 0.1% w/v; Chloramphenicol IP 0.5% w/v; Preservative q.s; Sterile Base q.s	IP	Eye/Ear Drops	0.1%, 0.5% w/v
32	Chloramphenicol Eye Drops IP	Chloramphenicol IP 0.5% w/v; Benzalkonium Chloride IP 0.01% v/v; Sterile Aqueous Base q.s	IP	Eye Drops	0.5% w/v
33	Ciprofloxacin Eye Drops IP	Ciprofloxacin IP 0.3% w/v; Benzalkonium Chloride IP 0.01% v/v; Sterile Aqueous Base q.s	IP	Eye Drops	0.3% w/v
34	Ofloxacin Eye Drops IP	Ofloxacin IP 0.3% w/v; Benzalkonium Chloride IP 0.01% v/v; Sterile Aqueous Base q.s	IP	Eye Drops	0.3% w/v
35	Gentamicin Sulphate Eye Drops IP	Gentamicin Sulphate IP 0.3% w/v; Benzalkonium Chloride IP 0.01% v/v; Sterile Aqueous Base q.s	IP	Eye Drops	0.3% w/v
36	Tobramycin Ophthalmic Ointment USP	Tobramycin Sulphate USP 0.3% w/w; Benzalkonium Chloride USP 0.01-0.02% v/w; Sterilized Paraffin Base q.s	USP	Ophthalmic Ointment	0.3% w/w
37	Tobramycin Sulphate HPMC Ophthalmic Solution	Tobramycin Sulphate IP 0.3% w/v; Hydroxypropylmethyl Cellulose IP 0.025% w/v; Benzalkonium Chloride IP 0.02% v/v; Sterile Aqueous Base q.s	IP	Ophthalmic Solution	0.3% w/v
38	Tobramycin Sulphate Dexamethasone Ophthalmic Solution	Tobramycin Sulphate IP 0.3% w/v; Dexamethasone Sodium Phosphate IP 0.1% w/v; Benzalkonium Chloride IP 0.02% v/v; Sterile Aqueous Base q.s	IP	Ophthalmic Solution	0.3%, 0.1% w/v
39	Tobramycin Dexamethasone HPMC Ophthalmic Solution	Tobramycin Sulphate IP 0.3% w/v; Dexamethasone Sodium Phosphate IP 0.1% w/v; Hydroxypropylmethyl Cellulose IP 0.025% w/v; Benzalkonium Chloride IP 0.02% v/v; Sterile Aqueous Base q.s	IP	Ophthalmic Solution	0.3%, 0.1% w/v
40	Tobramycin Betamethasone HPMC Ophthalmic Solution	Tobramycin Sulphate IP 0.3% w/v; Betamethasone Sodium Phosphate IP 0.1% w/v; Hydroxypropylmethyl Cellulose IP 0.025% w/v; Benzalkonium Chloride IP 0.02% v/v; Sterile Aqueous Base q.s	IP	Ophthalmic Solution	0.3%, 0.1% w/v
41	Tobramycin Fluorometholone Ophthalmic Suspension	Tobramycin Sulphate IP 0.3% w/v; Fluorometholone IP 0.1% w/v; Benzalkonium Chloride IP 0.02% v/v; Sterile Suspension Base q.s	IP	Ophthalmic Suspension	0.3%, 0.1% w/v
42	Tobramycin Fluorometholone HPMC Ophthalmic Suspension	Tobramycin Sulphate IP 0.3% w/v; Fluorometholone IP 0.1% w/v; Hydroxypropylmethyl Cellulose IP 0.025% w/v; Benzalkonium Chloride IP 0.02% v/v; Sterile Suspension Base q.s	IP	Ophthalmic Suspension	0.3%, 0.1% w/v

C. Sediaan Anti-Allergi dan Anti-Inflamasi

No	Nama Generik	Komposisi	Referensi	Klaim	Kekuatan
4	Alcaftadine Ophthalmic Solution	Alcaftadine 0.25% w/v; Benzalkonium Chloride IP 0.005% v/v; Sterile Aqueous Base q.s	–	Ophthalmic Solution	0.25% w/v
7	Azelastine HCL Eye Drop	Azelastine HCL IP 0.05% w/v; Benzalkonium Chloride IP 0.02% v/v; Sterile Aqueous Base q.s	IP	Eye Drop	0.05% w/v
8	Bromfenac Ophthalmic Solution	Bromfenac Sodium IP 0.09% w/v; Benzalkonium Chloride IP 0.02% v/v; Sterile Aqueous Base q.s	IP	Ophthalmic Solution	0.09% w/v
15	Brinzolamide Eye Drops IP	Brinzolamide IP 1.0% w/v; Benzalkonium Chloride IP 0.02% v/v; Sterile Suspension Base q.s	IP	Eye Drops	1.0% w/v
16	Brinzolamide Brimonidine Tartrate Eye Drops	Brinzolamide IP 1.0% w/v; Brimonidine Tartrate IP 0.2% w/v; Benzalkonium Chloride IP 0.02% v/v; Sterile Suspension Base q.s	IP	Eye Drops	1.0%, 0.2% w/v
23	Bepotastine Besilate Eye Drops	Bepotastine Besilate IP 1.5% w/v; Preservative q.s; Purified Water q.s	IP	Eye Drops	1.5% w/v
34	Fluorometholone Eye Drops USP	Fluorometholone USP 0.1% w/v; Benzalkonium Chloride USP 0.01% v/v; Sterile Aqueous Base q.s	USP	Eye Drops	0.1% w/v
35	Loteprednol Etabonate Ophthalmic Suspension	Loteprednol Etabonate IP 0.2% & 0.5% w/v; Preservative q.s; Sterile Suspension Base q.s	IP	Ophthalmic Suspension	0.2%, 0.5% w/v
36	Dexamethasone Sodium Phosphate Eye Drops USP	Dexamethasone Sodium Phosphate USP 0.1% w/v; Benzalkonium Chloride USP 0.01% v/v; Sterile Aqueous Base q.s	USP	Eye Drops	0.1% w/v
37	Difluprednate Ophthalmic Suspension	Difluprednate IP 0.03% w/v; Preservative q.s; Sterile Suspension Base q.s	IP	Ophthalmic Suspension	0.03% w/v
38	Fluconazole Eye/Ear Drops	Fluconazole IP 1.0% w/v; Benzalkonium Chloride IP 0.01% v/v; Sterile Base q.s	IP	Eye/Ear Drops	1.0% w/v

D. Sediaan Anti-Glaukoma

No	Nama Generik	Komposisi	Referensi	Klaim	Kekuatan
9	Bimatoprost Ophthalmic Solution	Bimatoprost 0.01% & 0.03% w/v; Benzalkonium Chloride IP 0.005% v/v; Sterile Aqueous Base q.s	IP	Ophthalmic Solution	0.01%, 0.03% w/v
10	Bimatoprost Timolol Maleate Ophthalmic Solution	Bimatoprost 0.03% & 0.01% w/v; Timolol Maleate IP 0.5% w/v; Benzalkonium Chloride IP 0.005% v/v; Sterile Aqueous Base q.s	IP	Ophthalmic Solution	0.03%, 0.01%, 0.5% w/v
11	Brimonidine Tartrate Eye Drop IP	Brimonidine Tartrate IP 0.2% & 0.1% w/v; Stabilised Oxychloro Complex IP 0.005% v/v; Sterile Aqueous Base q.s	IP	Eye Drop	0.2%, 0.1% w/v
12	Brimonidine Tartrate Eye Drop IP	Brimonidine Tartrate IP 0.15% w/v; Stabilised Oxychloro Complex IP 0.005% w/v; Sterile Aqueous Base q.s	IP	Eye Drop	0.15% w/v
13	Brimonidine Tartrate Timolol Maleate Ophthalmic Solution	Brimonidine Tartrate IP 0.2% w/v; Timolol Maleate IP 0.5% w/v; Stabilised Oxychloro Complex IP 0.005% w/v; Sterile Aqueous Base q.s	IP	Ophthalmic Solution	0.2%, 0.5% w/v
14	Brimonidine Tartrate Timolol Maleate Ophthalmic Solution	Brimonidine Tartrate IP 0.2% w/v; Timolol Maleate IP 0.5% w/v; Stabilised Oxychloro Complex IP 0.005% w/v; Sterile Aqueous Base q.s	IP	Ophthalmic Solution	0.2%, 0.5% w/v
21	Betaxolol Eye Drops IP	Betaxolol IP 0.25% & 0.5% w/v; Benzalkonium Chloride IP 0.01% v/v; Sterile Aqueous Base q.s	IP	Eye Drops	0.25%, 0.5% w/v
49	Timolol Maleate Eye Drops IP	Timolol Maleate IP 0.25% & 0.5% w/v; Benzalkonium Chloride IP 0.02% v/v; Sterile Aqueous Base q.s	IP	Eye Drops	0.25%, 0.5% w/v
50	Timolol Maleate Polyvinyl Alcohol Eye Drops	Timolol Maleate IP 0.5% w/v; Polyvinyl Alcohol IP 1.4% w/v; Benzalkonium Chloride IP 0.02% v/v; Sterile Aqueous Base q.s	IP	Eye Drops	0.5%, 1.4% w/v
51	Tropicamide Eye Drops IP	Tropicamide IP 1% w/v; Benzalkonium Chloride IP 0.02% v/v; Sterile Aqueous Base q.s	IP	Eye Drops	1% w/v
52	Tropicamide Phenylephrine HCL Eye Drops	Tropicamide IP 0.8% & 1.0% w/v; Phenylephrine HCL IP 5% w/v; Benzalkonium Chloride IP 0.02% v/v; Sterile Aqueous Base q.s	IP	Eye Drops	0.8%, 1.0%, 5% w/v
55	Travoprost Ophthalmic Solution IP	Travoprost IP 40 mcg; Benzalkonium Chloride IP 0.02% v/v; Sterile Suspension Base q.s	IP	Ophthalmic Solution	40 mcg
56	Travoprost Timolol Maleate Ophthalmic Solution IP	Travoprost IP 0.004% w/v; Timolol Maleate IP 0.5% w/v; Benzalkonium Chloride IP 0.02% v/v; Sterile Suspension Base q.s	IP	Ophthalmic Solution	0.004%, 0.5% w/v

E. Sediaan Pelumas dan Anti-Fatigue

No	Nama Generik	Komposisi	Referensi	Klaim	Kekuatan
24	Carboxymethyl Cellulose Sodium Eye Drops IP	Carboxymethyl Cellulose Sodium IP 0.5% w/v; Benzalkonium Chloride IP 0.01% v/v; Purified Water q.s	IP	Eye Drops	0.5% w/v
25	Carboxymethyl Cellulose Sodium Eye Drops IP	Carboxymethyl Cellulose Sodium IP 0.5% & 1.0% w/v; Preservative q.s; Purified Water q.s	IP	Eye Drops	0.5%, 1.0% w/v
29	Carboxymethyl Cellulose Sodium Glycerin Lubricant Eye Ointment	Carboxymethyl Cellulose Sodium IP 0.5% w/v; Glycerin IP 1.0% v/w; White Petrolatum q.s	IP	Eye Ointment	0.5% w/v
30	Sodium Carboxymethyl Cellulose N-Acetyl Carnosine Ophthalmic Solution	Sodium Carboxymethyl Cellulose IP 0.5% w/v; N-Acetyl Carnosine IP 0.02% w/v; Preservative q.s; Purified Water q.s	IP	Ophthalmic Solution	0.5%, 0.02% w/v
53	Polyvinyl Alcohol Eye Drops IP	Polyvinyl Alcohol IP 1.4% w/v; Preservative q.s; Purified Water q.s	IP	Eye Drops	1.4% w/v

F. Sediaan Anti-Inflamasi dan Kortikosteroid

No	Nama Generik	Komposisi	Referensi	Klaim	Kekuatan
31	Prednisolone Acetate Ophthalmic Suspension USP	Prednisolone Acetate USP 1.0% w/v; Benzalkonium Chloride USP 0.01% v/v; Sterile Suspension Base q.s	USP	Ophthalmic Suspension	1.0% w/v
32	Prednisolone Sodium Phosphate Eye Drops USP	Prednisolone Sodium Phosphate USP 0.12% w/v; Benzalkonium Chloride USP 0.01% v/v; Sterile Aqueous Base q.s	USP	Eye Drops	0.12% w/v
33	Dexamethasone Eye Drops IP	Dexamethasone IP 0.1% w/v; Benzalkonium Chloride IP 0.01% v/v; Sterile Aqueous Base q.s	IP	Eye Drops	0.1% w/v

G. Sediaan Anti-Infeksi Kombinasi

No	Nama Generik	Komposisi	Referensi	Klaim	Kekuatan
43	Homatropine Hydrobromide Eye Drops IP	Homatropine Hydrobromide IP 2% w/v; Preservative q.s; Purified Water q.s	IP	Eye Drops	2% w/v
44	Cocaine Hydrochloride Eye Drops IP	Cocaine Hydrochloride IP 4% & 10% w/v; Preservative q.s; Purified Water q.s	IP	Eye Drops	4%, 10% w/v
45	Emedastine Dibromide Ophthalmic Solution	Emedastine Dibromide IP 0.05% w/v; Benzalkonium Chloride IP 0.01% v/v; Sterile Aqueous Base q.s	IP	Ophthalmic Solution	0.05% w/v
46	Epinastine Ophthalmic Solution	Epinastine IP 0.05% w/v; Benzalkonium Chloride IP 0.01% v/v; Sterile Aqueous Base q.s	IP	Ophthalmic Solution	0.05% w/v
47	Fluorouracil Ophthalmic Solution	Fluorouracil IP 5% w/v; Preservative q.s; Sterile Water for Injection q.s	IP	Ophthalmic Solution	5% w/v
48	Hydrocortisone Ophthalmic Suspension USP	Hydrocortisone USP 1.0% w/v; Benzalkonium Chloride USP 0.01% v/v; Sterile Suspension Base q.s	USP	Ophthalmic Suspension	1.0% w/v

H. Sediaan Anti-Mikroba Lainnya

No	Nama Generik	Komposisi	Referensi	Klaim	Kekuatan
54	Sparfloxacin Ophthalmic Solution	Sparfloxacin IP 0.3% w/v; Benzalkonium Chloride IP 0.02% v/v; Sterile Aqueous Base q.s	IP	Ophthalmic Solution	0.3% w/v
55	Sparfloxacin HPMC Ophthalmic Solution	Sparfloxacin IP 0.3% w/v; Hydroxypropylmethyl Cellulose IP 0.025% w/v; Benzalkonium Chloride IP 0.02% v/v; Sterile Aqueous Base q.s	IP	Ophthalmic Solution	0.3% w/v
56	Tetrahydrozoline HCL Ophthalmic Solution USP	Tetrahydrozoline HCL USP 0.05% w/v; Benzalkonium Chloride IP 0.02% v/v; Sterile Aqueous Base q.s	USP	Ophthalmic Solution	0.05% w/v

I. Sediaan Kombinasi Lainnya

No	Nama Generik	Komposisi	Referensi	Klaim	Kekuatan
57	Naphazoline Hydrochloride Phenylephrine HCL Eye Drops	Naphazoline HCL IP 0.012% w/v; Phenylephrine HCL IP 0.15% w/v; Preservative q.s; Purified Water q.s	IP	Eye Drops	0.012%, 0.15% w/v
58	Phenylephrine HCL Eye Drops IP	Phenylephrine HCL IP 0.5% & 1.0% w/v; Preservative q.s; Purified Water q.s	IP	Eye Drops	0.5%, 1.0% w/v
59	Visine Eye Drops	Tetrahydrozoline HCL IP 0.05% w/v; Preservative q.s; Purified Water q.s	IP	Eye Drops	0.05% w/v
60	Zinc Sulphate Ophthalmic Solution IP	Zinc Sulphate IP 0.25% w/v; Preservative q.s; Purified Water q.s	IP	Ophthalmic Solution	0.25% w/v

3. Kategori Formulasi

Berdasarkan profil farmakologi dan indikasi terapeutik, formulasi ophtalmik dan otikal dapat diklasifikasikan ke dalam beberapa kategori utama:

Sediaan Antibiotik: Digunakan untuk pengobatan infeksi bakteri pada mata dan telinga, meliputi golongan aminoglikosida, fluoroquinolon, dan kloramfenikol
Sediaan Anti-Inflamasi: Berisi kortikosteroid atau NSAID untuk mengurangi peradangan
Sediaan Anti-Glaukoma: berfungsi menurunkan tekanan intraokular melalui berbagai mekanisme kerja
Sediaan Anti-Allergi: Mengandung antihistamin atau mast cell stabilizer untuk mengatasi reaksi alergi mata
Sediaan Pelumas: Fungsi sebagai artificial tears untuk mengatasi kekeringan mata
Sediaan Miostatik dan Midriatik: Mengandung agen yang mempengaruhi otot polos mata untuk diagnostik atau terapeutik

4. Kesimpulan

Formulasi ophtalmik dan otikal menuntut standar kualitas yang sangat ketat mengingat sensitivitas organ target. Setiap sediaan harus memenuhi persyaratan sterilitas, tonisitas, dan pH yang sesuai dengan jaringan mata. Penggunaan bahan pengawet seperti benzalkonium klorida perlu dioptimalkan untuk mencegah kontaminasi mikroba tanpa menyebabkan iritasi. Industri farmasi terus mengembangkan formulasi baru dengan sistem penghantaran obat yang lebih efektif seperti sediaan HPMC untuk meningkatkan bioavailabilitas dan durasi aksi obat pada mata.

Sumber: https://pharmaguidances.com/eye-ear-drops/