Diacerin 13739-02-1 Manufacturer Exporter MEDIOCON INC

 

Diacerin  Manufactured by MEDIOCON INC     

 

·   Name: Diacerin

 

·   CAS No: 13739-02-1

 

 

·   Molecular Weight: 368.294 g/mol

 

·   Molecular formula:  C₁₉H₁₂O₈

 

·   Synonyms:  Diacerhein, Diacetylrhein, Artrodar, and 1,8-Diacetoxy-3-carboxyanthraquinone

 

·   Appearance : Light yellow to Amber to Dark green powder to crystal

 

 

·   Solubility :    Insoluble in water, Highly Soluble in DMSO

    

·   Use :

Diacerin is a medication used to treat osteoarthritis. Its potential benefits include:

 

- Anti-inflammatory effects: Diacerin may help reduce inflammation in the joints.

- Pain relief: It may provide relief from pain associated with osteoarthritis.

- Slowing disease progression: Some studies suggest Diacerin may slow the progression of osteoarthritis.

 

Diacerin works by inhibiting interleukin-1 beta, a cytokine involved in the inflammatory process.

 

Consult a healthcare professional for personalized advice on using Diacerin or any other medication.

 

·      How is Diacerin  manufactured by MEDIOCON INC Synthesized?

Diacerein synthesis involves several steps:

- Starting Material: Rhein or aloe-emodin, anthraquinone derivatives, serve as starting materials.

- Acetylation Reaction: Diacerein is synthesized through an acetylation reaction, where acetic anhydride is used to introduce acetyl groups into the starting material.

- Catalyst: Zinc chloride may be employed as a catalyst to facilitate the reaction.

- Purification: The crude product undergoes purification processes like crystallization, washing, and vacuum drying to obtain high-purity diacerein.

- Quality Control: The final product is tested using analytical methods like HPLC, NMR spectroscopy, and mass spectrometry to ensure its quality and stability.

 

Some specific synthesis methods involve¹:

- High-yield synthesis: A method patented by Suzhou Nanomedicine R&D Co., Ltd. describes using specific temperature control and insulation conditions to achieve high yields.

- Chemical reaction: The synthesis involves chemical reactions like acetylation, with careful control of reaction conditions to optimize yields and purity.

 

Without specific information on MEDIOCON INC's synthesis process, these general steps provide an overview of how diacerein can be manufactured.

 

·         What are the different dosage forms of Diacerin  Manufactured by MEDIOCON INC?

Diacerein, manufactured by various companies, is available in several dosage forms, including:

- Tablets: Commonly used to treat osteoarthritis, these tablets are typically taken twice daily.

- Capsules: Another oral formulation option for managing osteoarthritis symptoms.

- Powdered Form: Some combinations of Diacerein with Glucosamine are available in powdered form, often used to manage osteoarthritis symptoms.

 

It's worth noting that specific products and dosage forms may vary depending on the manufacturer and region. MEDIOCON INC's specific offerings would require direct confirmation. Practo and other medical sources confirm Diacerein's availability in tablet and capsule forms.

·         How Diacerin  Manufactured by MEDIOCON INC   Dosage Forms are prepared?

 

The preparation of Diacerin dosage forms involves several steps:

- Tablets:

    - Formulation: Diacerin is mixed with excipients like binders, fillers, and lubricants.

    - Granulation: The mixture is granulated to improve flow and compression properties.

    - Compression: The granules are compressed into tablets using a tablet press.

- Capsules:

    - Filling: Diacerin powder is filled into hard gelatin or vegetarian capsules.

    - Weight variation control: Ensuring consistent fill weights is crucial for capsule uniformity.

- Quality Control: Both tablets and capsules undergo quality control tests, including:

    - Content uniformity: Verifying the active ingredient's consistent distribution.

    - Dissolution testing: Assessing the drug's release characteristics.

    - Stability testing: Evaluating the product's shelf life and storage conditions.

 

The exact preparation process may vary depending on MEDIOCON INC's specific formulation and manufacturing procedures.

·         What are the appropriate Dosage forms of Diacerin  Manufactured  by  MEDIOCON   INC?

The appropriate dosage forms of Diacerein manufactured by MEDIOCON INC may include:

- Oral Tablets: Typically containing 50mg of Diacerein, taken twice daily after meals.

- Capsules: May be available in various strengths, such as 50mg, with specific dosing instructions.

 

The choice of dosage form and strength depends on factors like:

- Patient needs: Severity of osteoarthritis symptoms and individual tolerance.

- Clinical guidelines: Recommendations from healthcare professionals and regulatory agencies.

- Product specifications: MEDIOCON INC's product labeling and instructions.

 

It's essential to follow the recommended dosage and administration guidelines provided by healthcare professionals or product labeling.

 

·         When should Diacerin  Manufactured by MEDIOCON INC be taken?

Diacerin, manufactured by MEDIOCON INC, is typically taken:

- With meals: To minimize gastrointestinal side effects, it's recommended to take Diacerin with meals.

- Twice daily: The usual dosage frequency is twice a day, morning and evening.

- Consistently: Taking Diacerin at the same time every day can help maintain consistent levels in the body.

 

It's essential to follow the specific dosing instructions provided by your healthcare provider or the product's labeling. If you have any questions or concerns, consult your healthcare provider for personalized guidance.

 

·         What are the effects And Side effects of Diacerin  Manufactured by MEDIOCON INC?

Diacerein, manufactured by MEDIOCON INC, is used to treat osteoarthritis. Its effects include¹ ²:

- Reducing inflammation: Diacerein works by inhibiting interleukin-1 beta, a protein involved in inflammation and cartilage destruction.

- Slowing cartilage damage: By reducing inflammation, Diacerein helps slow down cartilage damage and supports joint health.

Common Side Effects:

- Gastrointestinal issues:

    - Diarrhea: Can be severe and lead to dehydration if not managed properly.

    - Abdominal pain: May occur at the beginning of treatment.

    - Nausea: Can be accompanied by vomiting.

    - Flatulence: May subside as the body adjusts to the medication.

- Skin reactions:

    - Rashes: May be mild or severe.

    - Itching: Can be uncomfortable and require topical treatments.

- Other side effects:

    - Headache: Generally mild and temporary.

    - Dizziness: May occur, especially when starting treatment.

    - Urine discoloration: Harmless and reversible upon discontinuation.

    - Liver enzyme elevation: Rare, but regular monitoring is recommended.

    - Kidney function issues: Less common, but monitoring is advised.³

Serious Side Effects:

- Hypersensitivity reactions: Rare, but potentially life-threatening. Seek medical attention immediately if symptoms occur.

- Liver damage: Elevated liver enzymes can indicate potential liver stress or damage. Regular monitoring is crucial.

 

·         How is Diacerin  Manufactured by MEDIOCON  INC  Tested Qualitatively?

Diacerein manufactured by MEDIOCON INC can be tested qualitatively using various analytical techniques, including:

- High-Performance Liquid Chromatography (HPLC): Separates and detects Diacerein based on its chemical properties.

- Mass Spectrometry (MS): Identifies Diacerein's molecular structure and fragmentation pattern.

- Nuclear Magnetic Resonance (NMR) Spectroscopy: Determines Diacerein's molecular structure and purity.

- Infrared (IR) Spectroscopy: Analyzes Diacerein's molecular vibrations and functional groups.

- Thin-Layer Chromatography (TLC): Separates and identifies Diacerin based on its chemical properties.

 

These qualitative tests help ensure Diacerein's identity, purity, and quality, meeting regulatory and customer requirements.

 

·         Which tests are performed on Diacerin  Manufactured by MEDIOCON INC?

Diacerein manufactured by MEDIOCON INC may undergo various tests, including:

- Physical Tests:

    - Appearance: Visual inspection for color, texture, and consistency.

    - Solubility: Testing solubility in various solvents.

- Chemical Tests:

    - Purity: Determining the percentage of Diacerein present.

    - Identity: Confirming the presence of Diacerein using techniques like HPLC or NMR.

    - Impurity profiling: Detecting and quantifying impurities.

- Pharmaceutical Tests:

    - Content uniformity: Ensuring consistent Diacerein content in each dosage unit.

    - Dissolution testing: Assessing Diacerein's release characteristics.

    - Stability testing: Evaluating the product's shelf life and storage conditions.

- Microbial Tests:

    - Sterility testing: Ensuring the product is free from microorganisms.

    - Microbial limits testing: Testing for the presence of specific microorganisms.

 

These tests help ensure Diacerein's quality, safety, and efficacy, meeting regulatory and customer requirements.

 

 

·         What are the challenges in Manufacturing of Diacerin  Manufactured by MEDIOCON   INC API?

The manufacturing of Diacerein API can face several challenges, including:

- Complex synthesis process: Diacerein's synthesis involves multiple steps, requiring careful control of reaction conditions.

- Impurity control: Managing impurities and by-products is crucial to ensure API quality.

- Yield optimization: Maximizing yields while maintaining quality can be a challenge.

- Regulatory compliance: Meeting stringent regulatory requirements, such as GMP and ICH guidelines.

- Raw material sourcing: Ensuring consistent quality and supply of starting materials.

- Equipment and facility requirements: Specialized equipment and facilities may be needed.

- Stability and storage: Maintaining API stability and controlling storage conditions.

- Cost optimization: Balancing production costs with quality and regulatory requirements.

These challenges require careful planning, process optimization, and quality control measures to ensure the production of high-quality Diacerin API.

·         What are the challenges in manufacturing of Diacerin  Manufactured by MEDIOCON  INC ’s Dosage forms?

The manufacturing of Diacerin dosage forms by MEDCO_{2}N INC can face several challenges, including:

- Formulation development: Ensuring the stability and bioavailability of Diacerin in the chosen dosage form.

- Process optimization: Scaling up the manufacturing process while maintaining product quality and consistency.

- Equipment and facility requirements: Ensuring that equipment and facilities meet GMP standards and are suitable for Diacerin production.

- Quality control: Implementing robust quality control measures to detect and prevent defects or deviations.

- Regulatory compliance: Meeting regulatory requirements and guidelines for Diacerin dosage forms.

- Stability and shelf-life: Ensuring the product remains stable and effective throughout its shelf-life.

- Packaging and labeling: Ensuring proper packaging and labeling to maintain product integrity and provide clear instructions.

- Supply chain management: Managing the supply chain to ensure timely delivery of raw materials and finished products.

These challenges require careful planning, process optimization, and quality control measures to ensure the production of high-quality Diacerin dosage forms.

 

·         What is the Packing for Diacerin  Manufactured by MEDIOCON INC?

 

The packaging for Diacerin manufactured by MEDIOCON INC typically includes:

- Blisters or strips: Individual tablets or capsules are often packaged in blister packs or strips for convenience and protection.

- Bottles: Some products may be packaged in bottles, which can be made of glass or plastic, with child-resistant caps.

- Labeling: The packaging includes labeling with essential information, such as:

    - Product name: Diacerin

    - Dosage strength: e.g., 50mg

    - Manufacturer's name: MEDIOCON INC

    - Batch number: Unique identifier for the batch

    - Expiry date: Date indicating the product's shelf life

    - Storage instructions: Guidelines for storing the product

- Packaging materials: The packaging materials are chosen to protect the product from light, moisture, and other environmental factors.

 

The specific packaging design and materials may vary depending on the product and regulatory requirements.

 

·         What is shelf life Of Diacerin  Manufactured by MEDIOCON INC? 

 

The shelf life of Diacerin manufactured by MEDIOCON INC isn't publicly available. However, I can guide you on how to calculate shelf life or where to find it.¹

To determine the shelf life, you can:

- Check the packaging: Look for the expiration date or shelf life printed on the packaging.

- Use a shelf life calculator: If you know the manufactured date and expiration date, you can calculate the shelf life using a formula: Shelf Life = Expiration Date - Manufactured Date.

For specific information on Diacerin's shelf life, I recommend contacting MEDIOCON INC or consulting the product's documentation.

 

·         What should the label claim for Diacerin  Manufactured by MEDIOCON INC Include?

 

The label claim for Diacerin manufactured by MEDIOCON INC should include:

- Product Name: Diacerein

- Dosage Strength: e.g., 50mg

- Manufacturer's Name: MEDIOCON INC

- Batch Number: Unique identifier for the batch

- Expiry Date: Date indicating the product's shelf life

- Storage Instructions: Guidelines for storing the product (e.g., temperature, humidity)

- Directions for Use: Instructions for taking the medication (e.g., dosage, frequency)

- Cautionary Statements: Warnings or precautions for use (e.g., side effects, contraindications)

- Net Quantity: Amount of product in the package

- Regulatory Information: Compliance with relevant regulatory requirements (e.g., GMP, regulatory agency approvals)

The label claim should be accurate, clear, and compliant with regulatory requirements.

 

·         Where can Diacerin Manufactured by MEDIOCON INC are procured?

Diacerin  Manufactured by MEDIOCON INC   can be procured from various sources, depending on your location and requirements. Here are some options:

1.      FOR API

 MEDIOCON INC

Add: B-2, ARCH SARTHAK BUILDING, N-7 CIDCO

CHATRAPATI SAMBHAJI NAGAR-431003, MAHARASHTRA, INDIA

Mob/Whatsapp No: +91-8007719681, +91-9309999757, +91-9834786939

Sales Department: Email: sales@mediocon.com

Purchase Department: Email: purchase@mediocon.com

Marketing Department: Email: mktg@mediocon.com

HR Department: Email: hr@mediocon.com

Accounts Department: Email: accounts@mediocon.com          

Factory Address: Plot No 11, Shendra MIDC, Aurangabad-431154, Maharashtra, India Website:  www.mediocon.com 

Email id:info@mediocon.com           

 GST No: 27DHUPM2366D1ZZ

 

2.      For Dosage Forms :

     - Online Marketplaces: You can find Diacerin  Manufactured by MEDIOCON INC   products on online marketplaces like Amazon or e- commerce websites specializing in pharmaceuticals or skincare products.

 - Local Pharmacies or Skincare Stores: You can also check with local pharmacies or skincare stores in your area for Diacerin  Manufactured by MEDIOCON INC products.

 Remember to ensure the quality and authenticity of the Diacerin  Manufactured by MEDIOCON INC product, regardless of the procurement source.