Athena Pharmaceutiques Oral Dispersible Tablets

Athena Pharmaceutiques Oral Dispersible Tablets

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APIs // Active Pharmaceutical Ingredients

103 APIs, 84 USDMF, 22 CEP/COS, 8 JDMF, 2 KDMF, 21 NDC API, 12 Listed APIs

DEVELOPMENTS

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DOSSIERs // Finished Dosage Formulations

6 Dossiers, 6 FDA Orange Book

EXCIPIENTS

75 Listed Products, 53 Regulatory Filings, 50 USDMF, 5 CEP/COS

EXCIPIENTS BY INGREDIENTS

Povidone, polyethylene glycol, Crospovidone, Sodium Lauryl Sulfate, Cetostearyl Alcohol, Polyvinyl Acetate, Hard Fat, Ethyl Acrylate and Methyl Methacrylate, CETEARETH-12, Polyoxyl 35 Castor Oil, Polyvinyl Alcohol Graft Polyethylene Glycol Copolymer, Isopropyl Myristate, Sodium Cetostearyl Sulfate, Copovidone K25-31, Poloxamer 407, Lactose, Stearic Acid, Mannitol, Poloxamer 188, Decyl Oleate, Polysorbate 60, Propylene Glycol, Oleyl Alcohol, Hydrogenated Castor Oil, Stearyl Alcohol, Medium Chain Triglycerides, Diethylaminoethyl Methacrylate, Hydrated Silica, Pyrrolidone, Palmitic Acid, Poloxamer 124, Cetyl Alcohol, Triacetin, Polyoxyl 40 Hydrogenated Castor Oil, Methyl Methacrylate, Polyvinyl Alcohol, Polyoxyl 20 Cetostearyl Ether, Poloxamer, Lauryl Sulfate, Poloxamer 338, Cetyl Palmitate, Polysorbate 20, Myristyl Alcohol, Glyceryl Monostearate, Cocoyl Caprylocaprate, Polysorbate 80, Octyldodecanol, Cetearyl Ethylhexanoate, Polyoxyl 15 Hydroxystearate

EXCIPIENTS BY APPLICATIONS

Solubilizers, Granulation, Topical, Direct Compression, Thickeners and Stabilizers, Controlled & Modified Release, Coating Systems & Additives, Fillers, Diluents & Binders, Lubricants & Glidants, Taste Masking, Film Formers & Plasticizers, Chewable & Orodispersible Aids, Parenteral, Disintegrants & Superdisintegrants, API Stability Enhancers

INSPECTIONS & REGISTRATIONS

43 FDA, 21 EDQM, 7 GDUFA

List of Excipients

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KOLLICOAT IR

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LM Application #LearnMore

Applications: For Instant Release Coating, Powerful and peroxide free wet binder for oxidation-sensitive drugs. Flexible and wash resistant film former in topical films.

Ingredient(s): Polyvinyl Alcohol Graft Polyethylene Glycol Copolymer

Dosage Form: Capsule, Granule / Pellet, Softgel Capsule, Softgels, Tablet, Topical Film

Category: Fillers, Diluents & Binders, Granulation

Route of Administration (Grade): Not Available

Pharmacopoeia Reference: Ph. Eur.: Macrogol Poly(vinyl alcohol) Grafted Copolymer; USP-NF: Ethylene Glycol and Vinyl Alcohol Graft Copolymer; JPE: Methacrylic Acid Copolymer LD

Technical Specifications: Not Available

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KOLLICOAT MAE 100 P

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LM Application #LearnMore

Applications: Enteric coating with release above pH 5.5 (partially preneutralized powder)

Ingredient(s): Methacrylic Acid & Ethyl Acrylate Copolymer

Dosage Form: Capsule, Granule / Pellet, Softgel Capsule, Tablet

Category: Coating Systems & Additives, Controlled & Modified Release

Route of Administration (Grade): Not Available

Pharmacopoeia Reference: Ph. Eur.: Methacrylic Acid

Technical Specifications: Not Available

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KOLLICOAT MAE 100-55

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Applications: Enteric coating with release above pH 5.5 (non-neutralized powder), fast redispersing for aqueaous and organic coating

Ingredient(s): Methacrylic Acid & Ethyl Acrylate Copolymer

Dosage Form: Capsule, Granule / Pellet, Softgel Capsule, Tablet

Category: Coating Systems & Additives, Controlled & Modified Release

Route of Administration (Grade): Not Available

Pharmacopoeia Reference: Not Available

Technical Specifications: Not Available

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KOLLICOAT MAE 30 DP

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Applications: Enteric coating with release above pH 5.5 (30 % solids content dispersion)

Ingredient(s): Methacrylic Acid & Ethyl Acrylate Copolymer

Dosage Form: Capsule, Granule / Pellet, Softgel Capsule, Tablet

Category: Coating Systems & Additives, Controlled & Modified Release, Taste Masking

Route of Administration (Grade): Not Available

Pharmacopoeia Reference: Ph. Eur.: Methacrylic Acid

Technical Specifications: Not Available

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KOLLICOAT PROTECT

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Applications: Flexible water soluble instant release coating polymer, especially used for moisture protection

Ingredient(s): Polyvinyl Alcohol; Polyvinyl Alcohol Graft Polyethylene Glycol Copolymer

Dosage Form: Capsule, Granule / Pellet, Softgel Capsule, Tablet

Category: Coating Systems & Additives, Controlled & Modified Release

Route of Administration (Grade): Not Available

Pharmacopoeia Reference: Excipient based on Kollicoat® IR and monographed raw materials

Technical Specifications: Not Available

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KOLLICOAT SMARTSEAL 30 D

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Applications: Taste masking at very low coating levels, suitable for pellets & particles for ODTs.

Ingredient(s): CETEARETH-12; Diethylaminoethyl Methacrylate; Methyl Methacrylate; Sodium Lauryl Sulfate

Dosage Form: Capsule, Granule / Pellet, Softgel Capsule, Tablet

Category: Coating Systems & Additives, Taste Masking

Route of Administration (Grade): Not Available

Pharmacopoeia Reference: Not Available

Technical Specifications: Not Available

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KOLLICOAT SR 30 D

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Applications: pH-independent sustained release coating for small particles, pellets, granules and tablets. Sprayable polymeric film former. Flexible. Wash resistant.

Ingredient(s): Polyvinyl Acetate; Sodium Lauryl Sulfate

Dosage Form: Capsule, Granule / Pellet, Softgel Capsule, Tablet, Topical Film

Category: Coating Systems & Additives, Controlled & Modified Release, Taste Masking

Route of Administration (Grade): Not Available

Pharmacopoeia Reference: Ph. Eur.: Poly(vinyl acetate) dispersion 30 per cent; USP: Polyvinyl Acetate Dispersion

Technical Specifications: Not Available

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KOLLICREAM 3C

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LM Application #LearnMore

Applications: Medium spreadability, extremely mild, solvent for lipophilic drugs, enhances skin penetration

Ingredient(s): Coco Caprylate Caprate

Dosage Form: Cream / Lotion / Ointment, Emulsion, Gel

Category: Topical

Route of Administration (Grade): Not Available

Pharmacopoeia Reference: Ph. Eur.: Cocoyl caprylocaprate, Coco-caprylate-caprate

Technical Specifications: Not Available

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KOLLICREAM CP 15

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Applications: Solid, slow spreading with rich feeling. Solvent for lipophilic drugs.

Ingredient(s): Cetyl Palmitate

Dosage Form: Cream / Lotion / Ointment, Emulsion

Category: Topical

Route of Administration (Grade): Not Available

Pharmacopoeia Reference: Ph. Eur: Cetyl palmitate 15

Technical Specifications: Not Available

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KOLLICREAM DO

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Applications: Medium spreadability, Solvent for lipophilic drugs, enhances skin penetration.

Ingredient(s): Decyl Oleate

Dosage Form: Cream / Lotion / Ointment, Emulsion, Gel

Category: Topical

Route of Administration (Grade): Not Available

Pharmacopoeia Reference: Ph. Eur.: Decyl oleate

Technical Specifications: Not Available

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KOLLICREAM IPM

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Applications: Fast spreading with light & fresh feeling, solvent for lipophilic drugs, enhances skin penetration

Ingredient(s): Isopropyl Myristate

Dosage Form: Cream / Lotion / Ointment, Emulsion, Gel

Category: Topical

Route of Administration (Grade): Not Available

Pharmacopoeia Reference: Ph. Eur., USP-NF: Isopropyl myristate

Technical Specifications: Not Available

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KOLLICREAM OA

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Applications: Medium spreadability, solvent for lipophilic drugs, enhances skin penetration

Ingredient(s): Oleyl Alcohol

Dosage Form: Cream / Lotion / Ointment, Emulsion, Gel

Category: Topical

Route of Administration (Grade): Not Available

Pharmacopoeia Reference: Ph. Eur., USP-NF: Oleyl alcohol

Technical Specifications: Not Available

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KOLLICREAM OD

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Applications: Medium spreadability, solvent for lipophilic drugs, enhances skin penetration, effective in exceptionally wide pH range

Ingredient(s): Octyldodecanol

Dosage Form: Cream / Lotion / Ointment, Emulsion, Gel

Category: Topical

Route of Administration (Grade): Not Available

Pharmacopoeia Reference: Ph. Eur., USP-NF: Octyldodecanol

Technical Specifications: Not Available

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KOLLIDON 12 PF

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LM Application #LearnMore

Applications: Solubilizing matrix, crystallization inhibitor & stabilizer in injectables and ophthalmic products

Ingredient(s): Povidone

Dosage Form: Capsule, Emulsion, Granule / Pellet, Softgel Capsule, Solution, Tablet, Transdermal patches

Category: Parenteral, Solubilizers

Route of Administration (Grade): Not Available

Pharmacopoeia Reference: Ph. Eur., USP, JP

Technical Specifications: Not Available

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KOLLIDON 17 PF

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LM Application #LearnMore

Applications: Solubilizing matrix, crystallization inhibitor & stabilizer in injectables and ophthalmic products

Ingredient(s): Povidone

Dosage Form: Capsule, Emulsion, Softgel Capsule, Solution, Tablet, Transdermal patches

Category: Parenteral, Solubilizers

Route of Administration (Grade): Not Available

Pharmacopoeia Reference: Ph. Eur., USP: Povidone; JPE: Povidone K 17

Technical Specifications: Not Available

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KOLLIDON 25

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LM Application #LearnMore

Applications: Solubilization, dispersion, crystallization inhibition, instant release matrices & spray drying

Ingredient(s): Povidone

Dosage Form: Capsule, Tablet, Transdermal Patch

Category: Controlled & Modified Release

Route of Administration (Grade): Not Available

Pharmacopoeia Reference: Ph. Eur., USP, JP

Technical Specifications: Not Available

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KOLLIDON 30

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LM Application #LearnMore

Applications: Solubilization, dispersion, crystallization inhibition, instant release matrices & spray drying

Ingredient(s): Povidone

Dosage Form: Capsule, Tablet, Transdermal Patch, Transdermal patches

Category: Controlled & Modified Release, Solubilizers

Route of Administration (Grade): Not Available

Pharmacopoeia Reference: Ph. Eur., USP, JP: Povidone

Technical Specifications: Not Available

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KOLLIDON 30 LP

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LM Application #LearnMore

Applications: Binder for peroxide sensitive drugs in solid oral dosage forms. Drug solubilizer with low peroxide in transdermal patches.

Ingredient(s): Povidone

Dosage Form: Capsule, Granule / Pellet, Tablet

Category: Fillers, Diluents & Binders, Granulation

Route of Administration (Grade): Not Available

Pharmacopoeia Reference: Ph. Eur., USP, JP: Povidone

Technical Specifications: Not Available

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KOLLIDON 90 F

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LM Application #LearnMore

Applications: Tablet binding, thickener, stabilizers of suspensions, reduces sedimentation, crystallization inhibition.

Ingredient(s): Povidone

Dosage Form: Capsule, Granule / Pellet, Softgel Capsule, Suspension, Tablet

Category: Fillers, Diluents & Binders, Granulation, Solubilizers

Route of Administration (Grade): Not Available

Pharmacopoeia Reference: Ph. Eur., USP, JP: Povidone

Technical Specifications: Not Available

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KOLLIDON CL

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Applications: Maximum disintegration

Ingredient(s): Polyvinylpyrrolidone Crosslinked

Dosage Form: Capsule, Granule / Pellet, Tablet

Category: Direct Compression, Disintegrants & Superdisintegrants

Route of Administration (Grade): Not Available

Pharmacopoeia Reference: Ph. Eur., USP, JP: Crospovidone Type A

Technical Specifications: Not Available

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KOLLIDON CL-F

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Applications: Kollidon CL-F has a balance of strong disintegration and optimal surface homogeneity.

Ingredient(s): Polyvinylpyrrolidone Crosslinked

Dosage Form: Capsule, Granule / Pellet, Orodispersible Tablet, Tablet

Category: Chewable & Orodispersible Aids, Direct Compression, Disintegrants & Superdisintegrants

Route of Administration (Grade): Not Available

Pharmacopoeia Reference: Ph. Eur., USP, JP: Crospovidone Type A

Technical Specifications: Not Available

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KOLLIDON CL-M

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LM Application #LearnMore

Applications: Roller compaction & direct compression including slight disintegration functionality, Reduces sedimentation in suspensions. Solubilizer in transdermal patches.

Ingredient(s): Polyvinylpyrrolidone Crosslinked

Dosage Form: Capsule, Granule / Pellet, Tablet

Category: Direct Compression, Fillers, Diluents & Binders, Granulation

Route of Administration (Grade): Not Available

Pharmacopoeia Reference: Ph. Eur., USP, JP: Crospovidone Type B

Technical Specifications: Not Available

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KOLLIDON CL-SF

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LM Application #LearnMore

Applications: Kollidon CL-SF acts as a dry binder and super disintegrant suitable for small tablets and orally disintegrating tablets (ODTs). It provides pleasant mouthfeel due to finer particles.

Ingredient(s): Polyvinylpyrrolidone Crosslinked

Dosage Form: Granule / Pellet, Orodispersible Tablet, Tablet

Category: Chewable & Orodispersible Aids, Direct Compression, Granulation

Route of Administration (Grade): Not Available

Pharmacopoeia Reference: Ph. Eur., USP, JP: Crospovidone Type B

Technical Specifications: Not Available

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KOLLIDON SR

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LM Application #LearnMore

Applications: For non-erodible matrices using direct compression, Controlled release matrix. Matrix former in transdermal patches and topical films.

Ingredient(s):