Iprifavone 35212-22-7 Manufacturer Exporter Supplier MEDIOCON INC

 

 

Iprifavone Manufactured by MEDIOCON INC     

 

   Name: Iprifavone

CAS No:  35212-22-7

Molecular Weight: 280.32 g/mol

Molecular formula:  C₁₈H₁₆O₃

Synonyms:  Osteofix, Osten, Yambolap, Ipriflavona (Spanish), Ipriflavonum (Latin), and the chemical name 7-isopropoxyisoflavone

Appearance:  White to almost white powder to crystal or white crystalline powder.

 Solubility :  poorly soluble in water and ethanol.

Use :

Ipriflavone is a synthetic isoflavone derived from soy, commonly used to treat and prevent osteoporosis in postmenopausal women. It works by promoting calcium absorption into bones, inhibiting bone breakdown, and maintaining bone density. This medication is also used for Paget's disease, renal osteodystrophy, and reducing bone loss caused by chronic kidney disease or paralysis associated with stroke.¹ ² ³

Benefits:

- Osteoporosis Treatment and Prevention: Ipriflavone helps maintain bone density, preventing fractures and osteoporosis-related pain.

- Bone Pain Relief: It reduces pain associated with osteoporosis and Paget's disease.

- Combination Therapy: When used with estrogen, ipriflavone enhances bone strength and prevents osteoporosis; adding calcium further boosts its effectiveness.

Dosage and Administration:

The recommended dosage varies depending on the condition:

- Osteoporosis: 200 mg three times daily or 600 mg daily with 1000 mg calcium.

- Paget's Disease: 600-1200 mg daily.

- Renal Osteodystrophy: 400-600 mg daily.

Side Effects and Precautions:

While generally safe, ipriflavone may cause gastrointestinal issues, headaches, or dizziness. Long-term use can lead to lymphocytopenia (low white blood cell count), increasing infection risk. It's essential to monitor white blood cell counts and liver function during treatment.⁴

Interactions:

Ipriflavone may interact with medications changed by the liver, immunosuppressants, and theophylline, affecting their efficacy and safety. Consult a healthcare provider before starting ipriflavone, especially if you have underlying medical conditions or take other medications.

 How is  Iprifavone manufactured by MEDIOCON INC Synthesized?

Ipriflavone is synthesized through a multi-step chemical process. Here's a general overview:

Synthesis Steps1. Starting Material: The synthesis begins with 2,4-dihydroxydeoxybenzoin (DHB) or 7-hydroxyisoflavone.

2. Reaction with Ethyl Orthoformate: DHB reacts with ethyl orthoformate in the presence of a catalyst, such as morpholine, to form 7-hydroxyisoflavone.

3. Alkylation: 7-Hydroxyisoflavone is then alkylated with isopropyl halide (e.g., isopropyl chloride or bromide) in the presence of a base, such as potassium carbonate, to form Ipriflavone.

4. Purification: The crude Ipriflavone is then purified through recrystallization or chromatography to obtain the final product.

Reaction Conditions- Temperature: 100-150°C for the reaction with ethyl orthoformate and 50-100°C for the alkylation step

- Solvents: Dimethylformamide (DMF), toluene, or ethanol

- Catalysts: Morpholine, potassium carbonate

Yield and PurityThe synthesis process typically yields Ipriflavone with a high purity (>99%) and a yield of around 80-90%. However, the actual yield and purity may vary depending on the specific reaction conditions and purification methods used

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

Ipriflavone is available in various dosage forms, primarily in oral formats. Here are some of the common forms:

- Capsules: This is one of the most common forms of Ipriflavone, often containing 200-300 mg of the active ingredient per capsule. For example, Nutrilite Bone Health with Ipriflavone capsules contain 300mg of Ipriflavone per serving.

- Tablets: Ipriflavone tablets are another oral dosage form, typically containing 200 mg of Ipriflavone per tablet.

- Suspensions: Though less common, Ipriflavone suspensions may be prescribed for specific patient needs.

When it comes to dosage, the typical range is between 200 to 600 mg per day, divided into two or three doses. It's recommended to take Ipriflavone with meals to enhance absorption. The dosage might vary depending on the condition being treated, such as osteoporosis prevention or treatment, and individual patient factors.¹ ² ³

Some specific dosage guidelines include:

- For Osteoporosis: 200 mg three times a day, taken with calcium supplements.

- For Paget's Disease: 600-1200 mg daily, divided into multiple doses.

It's essential to consult a healthcare professional for personalized dosage instructions and to ensure safe usage.

 How Iprifavone Manufactured by MEDIOCON INC   Dosage Forms are prepared?

Ipriflavone dosage forms are prepared using various methods, depending on the desired formulation. Here are some common forms and preparation methods:

- Tablets: Ipriflavone tablets are typically prepared using a direct compression method, where the active ingredient is mixed with excipients like binders, fillers, and lubricants, and then compressed into tablets.

- Capsules: Ipriflavone capsules are prepared by filling hard gelatin capsules with a mixture of the active ingredient and excipients like binders, fillers, and lubricants.

- Oral Solutions/Suspensions: Ipriflavone oral solutions or suspensions are prepared by dissolving or suspending the active ingredient in a suitable vehicle, such as water or oil, with added excipients like sweeteners, flavorings, and preservatives.¹ ²

 

The preparation of Ipriflavone dosage forms involves several key considerations, including:

- Absorption Enhancement: Using oily vehicles can promote absorption of Ipriflavone, enabling simplified dosage.

- Dosage Form Selection: Choosing the right dosage form depends on factors like patient needs, desired onset of action, and duration of therapy.

- Quality Control: Ensuring the quality of the final product involves testing for parameters like content uniformity, dissolution, and stability.

Some specific patents and formulations for Ipriflavone dosage forms include:

- Patent IT1241079B: Describes oral pharmaceutical compositions containing Ipriflavone, characterized by the use of oily vehicles that promote absorption.

- Patent US5504105A: Discusses pharmaceutical compositions containing Ipriflavone, with a focus on process and therapeutic use.

It's essential to consult relevant pharmaceutical guidelines and regulations, like the USP or FDA guidelines, for detailed information on preparing Ipriflavone dosage forms.

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

Ipriflavone is available in various dosage forms, primarily oral formats, to help prevent and treat weak bones in postmenopausal women and relieve pain associated with osteoporosis. The common dosage forms include¹ ² ³:

- Capsules: 200-300 mg/capsule, 1-2 capsules per dose, taken twice daily. For example, Nutrilite Bone Health with Ipriflavone capsules contain 300mg of Ipriflavone per serving.

- Tablets: 200 mg/tablet, taken three times a day. The recommended dose for Ipriflavone is 200 mg tablet, taken orally three times a day.

- Oral Solutions/Suspensions: Though less common, Ipriflavone oral solutions or suspensions may be prescribed for specific patient needs.

 

When it comes to dosage, the typical range is between 200 to 600 mg per day, divided into two or three doses. It's recommended to take Ipriflavone with food to enhance absorption and minimize gastrointestinal discomfort.⁴ ⁵

 

Some specific guidelines include:

- For Osteoporosis: 200 mg three times a day, taken with calcium supplements.

- For Paget's Disease: 600-1200 mg daily, divided into multiple doses.

 

It's essential to consult a healthcare professional for personalized dosage instructions and to ensure safe usage, especially considering potential interactions with other medications or underlying medical conditions.

When should Iprifavone Manufactured by MEDIOCON INC be taken?

Ipriflavone should be taken orally, typically in the form of tablets or capsules, with a recommended dosage of 200-600 mg per day divided into two or three doses. It's often advised to take Ipriflavone with food to enhance absorption and minimize gastrointestinal discomfort.¹ ² ³

 

Best Time to Take Ipriflavone:

 

- Take Ipriflavone three times a day, spaced evenly apart, as directed by your healthcare provider.

- For osteoporosis prevention and treatment, a common dosage is 200 mg three times a day, taken with calcium supplements.

- For Paget's disease, the dosage may range from 600-1200 mg daily, divided into multiple doses.⁴ ⁵

Important Considerations:

- Avoid taking antacids containing aluminum or magnesium simultaneously with Ipriflavone, as they may interfere with absorption.

- Calcium and vitamin D supplements are often co-prescribed with Ipriflavone to enhance its bone-protective effects, but take them at different times of the day.

- Consult your healthcare provider before starting Ipriflavone, especially if you have underlying medical conditions or take other medications.

Remember to adhere strictly to the prescribed dosage and consult your healthcare provider regularly to monitor treatment efficacy and potential side effects.

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

Ipriflavone is a synthetic isoflavone derived from soy, commonly used to prevent and treat weak bones (osteoporosis) in postmenopausal women, relieve pain associated with osteoporosis, and treat Paget's disease. Let's break down its effects and potential side effects.

 

Positive Effects:

 

- Bone Density Improvement: Ipriflavone promotes calcium absorption into bones and inhibits bone breakdown, preventing osteoporosis.

- Pain Relief: It significantly reduces pain due to osteoporosis and is as effective as calcitonin.

- Combination Therapy: When used with estrogen and calcium, ipriflavone prevents bone loss and increases bone strength in older women.¹ ²

 

Side Effects:

 

- Gastrointestinal Issues: Stomach pain, diarrhea, nausea, vomiting, and gastric or duodenal ulcers.

- Low White Blood Cell Count (Lymphocytopenia): Long-term use may decrease white blood cell count, increasing infection risk.

- Allergic Reactions: Rare cases of rash, itching, swelling, dizziness, or difficulty breathing.

- Headaches: Mild headaches have been reported, which may subside with dosage reduction or discontinuation.

- Dizziness: Some individuals may experience dizziness when taking ipriflavone.³ ⁴

Precautions and Interactions:

- Pregnancy and Breastfeeding: Avoid using ipriflavone due to insufficient safety data.

- Weak Immune System: Use with caution, as ipriflavone may further decrease immune function.

- Liver and Kidney Disease: Monitor kidney and liver parameters periodically when using ipriflavone.

- Interactions with Medications: Ipriflavone may interact with blood thinners, anti-inflammatory drugs, and hormone replacement therapies.

It's essential to consult a healthcare provider before starting ipriflavone, especially if you have underlying medical conditions or take other medications.

  How is Iprifavone  Manufactured by MEDIOCON  INC  Tested Qualitatively?

Qualitative testing of Ipriflavone involves various biochemical assays to detect its presence and identify its properties. Since Ipriflavone is a synthetic isoflavone derivative, tests similar to those for isoflavones and flavonoids can be applied.

 

General Tests:

 

- Molisch Test: A general test for carbohydrates, which can also apply to Ipriflavone due to its glycosidic structure. A purple ring forms at the interface of the sample and sulfuric acid, indicating a positive result.

- Benedict's Test: Detects reducing sugars. Ipriflavone might not directly respond, but its metabolites or breakdown products could.

- Iodine Test: Used to distinguish starch and glycogen. Ipriflavone doesn't contain these polysaccharides, but the test principle can be adapted for other complex structures.¹

 

Specific Tests:

 

- Pfeiffer's Test: Detects histidine, but its principle can be applied to identify specific amino acid interactions with Ipriflavone.

- Ninhydrin Test: Identifies alpha-amino groups. While not directly applicable, similar tests can detect Ipriflavone's interaction with proteins or amino acids.

- Bradford Test: Measures protein concentration. Adapted versions can quantify Ipriflavone in solutions.²

Chromatographic Methods:

- Thin-Layer Chromatography (TLC): Separates and identifies Ipriflavone based on its mobility in a solvent system.

- High-Performance Liquid Chromatography (HPLC): Quantifies Ipriflavone in various samples, including pharmaceuticals.

Keep in mind that specific tests might require modifications based on Ipriflavone's unique structure and properties. Consult recent research articles or biochemical resources for the most up-to-date testing protocols.

   Which tests are performed on Iprifavone Manufactured by  MEDIOCON INC ?

Ipriflavone testing involves various biochemical assays and chromatographic methods to detect its presence and identify its properties. Here are some tests performed on Ipriflavone¹ ² ³:

- Physical and Chemical Tests: These include tests for appearance, solubility, melting point, and infrared spectroscopy to confirm its identity.

- High-Performance Liquid Chromatography (HPLC): This method is used to determine the purity and content of Ipriflavone in pharmaceutical preparations.

- Thin-Layer Chromatography (TLC): This test helps identify Ipriflavone and detect potential impurities.

- Biochemical Assays: These tests evaluate Ipriflavone's biological activity, such as its ability to inhibit bone resorption and promote calcium absorption in bones.

- Toxicity Tests: These assessments determine the safety profile of Ipriflavone, including its potential side effects and interactions with other medications.

- Clinical Trials: Randomized controlled trials and double-blind studies are conducted to evaluate Ipriflavone's efficacy in preventing and treating osteoporosis, Paget's disease, and other conditions.

 

Some specific tests for Ipriflavone include⁴:

- Molisch Test: Detects carbohydrates

- Benedict's Test: Detects reducing sugars

- Iodine Test: Distinguishes starch and glycogen

- Pfeiffer's Test: Detects histidine

- Ninhydrin Test: Identifies alpha-amino groups

- Bradford Test: Measures protein concentration

 

These tests help ensure the quality, safety, and efficacy of Ipriflavone as a dietary supplement or pharmaceutical agent.

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

Manufacturing Iprifavone API poses several challenges that can impact the quality, safety, and efficacy of the final product. Here are some key challenges:

 

Regulatory Compliance

 

Iprifavone API manufacturing must adhere to strict regulatory guidelines set by agencies like the FDA and EMA. Ensuring compliance with Good Manufacturing Practices (GMP) and maintaining thorough documentation is crucial to avoid regulatory issues.¹ ²

 

Complex Chemistry and Process Optimization

 

The synthesis of Iprifavone involves complex chemical reactions, requiring manufacturers to have a deep understanding of process optimization, impurity control, and yield enhancement. Scaling up production while maintaining consistency and quality is a significant challenge.³

 

Quality Control and Assurance

Maintaining high-quality standards throughout the manufacturing process is essential. This includes rigorous testing, monitoring, and documentation of parameters like impurities, potency, and stability.

Supply Chain Management

Iprifavone API manufacturing relies on a network of suppliers for raw materials and intermediates. Disruptions in the supply chain can impact production timelines and quality. Manufacturers must build strong relationships with reliable suppliers and implement robust inventory management systems.

Environmental Sustainability

The manufacturing process has a significant environmental impact due to the use of chemicals, solvents, and energy-intensive processes. Adopting green chemistry principles and sustainable manufacturing technologies can help minimize this impact.

Cost-Efficiency and Scalability

Achieving cost-effective production while scaling up manufacturing is a challenge. Manufacturers must optimize synthetic routes, reduce waste, and implement efficient purification processes.

Technology Transfer and Scale-Up

Transferring laboratory-scale processes to commercial-scale production poses technical and logistical hurdles. Detailed batch records, SOPs, and pilot-scale runs are essential for successful technology transfer.

Impurity Control and Profiling

Identifying and controlling impurities is critical to ensure product quality and regulatory compliance. Advanced analytical methods like HPLC, LC-MS, and NMR are used to detect trace impurities.

Addressing these challenges requires a strategic approach, robust planning, and the adoption of innovative technologies and methodologies. By overcoming these challenges, manufacturers can ensure the production of high-quality Iprifavone API that meets regulatory standards and patient needs.

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

Manufacturing Iprifavone dosage forms poses several challenges that can impact the quality, safety, and efficacy of the final product. Here are some key challenges:

 

Solid Dosage Forms

 

- Maintaining Stability: Ensuring the stability of the drug substance throughout the manufacturing process is crucial, requiring careful control of environmental factors like temperature and humidity.

- Consistent Quality: Achieving consistent quality across large batches can be difficult, particularly when scaling up production.

- Tablet Compression: Tablet compression is a critical stage in production, requiring precise control over parameters like weight, hardness, and disintegration time.

- Regulatory Compliance: Meeting regulatory requirements for quality control, documentation, and validation is essential to avoid compliance issues.¹

 

Liquid Dosage Forms

 

- Stability Issues: Liquid dosage forms are susceptible to chemical and physical changes over time, leading to degradation, alteration of drug potency, and contamination.

- Microbial Contamination: Liquid formulations are prone to microbial growth, requiring careful selection and justification of preservatives.

- Poor Solubility: Some drugs, like Iprifavone, are difficult to solubilize in liquid media, leading to precipitation and potential clogging of equipment.

- Product Uniformity: Ensuring uniform dosing, packaging, and labeling is critical to prevent adverse events and product recalls.² ³

 

Common Challenges

- Supply Chain Management: Disruptions in the supply chain can impact production timelines and quality, emphasizing the need for strong relationships with reliable suppliers.

- Environmental Sustainability: Adopting green chemistry principles and sustainable manufacturing technologies can help minimize environmental impact.

- Cost-Efficiency and Scalability: Achieving cost-effective production while scaling up manufacturing requires optimizing synthetic routes, reducing waste, and implementing efficient purification processes.

Addressing these challenges requires a strategic approach, robust planning, and the adoption of innovative technologies and methodologies to ensure the production of high-quality Iprifavone dosage forms.

What is the Packing for Iprifavone Manufactured by MEDIOCON INC?

Ipriflavone packing varies depending on the product form and intended use. Here are some common packaging options:

- Tablets/Capsules: Ipriflavone tablets or capsules are often packaged in Al/Blister or bottles, with specific configurations like 10*10 tablets per pack.

- Powder: Ipriflavone powder is typically packed in bags, with quantities ranging from 1 kg to 25 kg, commonly used for formulation purposes.

- Softgel Capsules: Softgel capsules containing Ipriflavone, Alfacalcidol, and Calcium Carbonate are packaged in 10*10 strips.

- Vegetarian Capsules: Some Ipriflavone supplements come in 90-capsule bottles, with each serving size being 2 capsules.

In terms of storage, Ipriflavone should be kept in a cool, dry place, with some products requiring refrigeration at 2-8°C. Always check the product label for specific storage instructions.

What is shelf life Of Iprifavone Manufactured by MEDIOCON INC? 

Ipriflavone has a shelf life of 2 years when properly stored. It's essential to store it in a cool, dry, and ventilated place, away from moisture and heat, to maintain its potency and effectiveness.

 

Storage Conditions:

 

- Store in a cool, dry place

- Avoid exposure to moisture and heat

- Keep the container tightly closed

 

Factors Affecting Shelf Life:

 

- Temperature: Store at room temperature, below 25°C (77°F)

- Humidity: Keep the storage area dry, with low humidity

- Light: Protect from direct sunlight

 

Proper storage ensures Ipriflavone remains effective for its intended purpose, preventing and treating weak bones (osteoporosis) in older women, relieving pain associated with osteoporosis, and treating Paget's disease.

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

The label claim for Ipriflavone should include the following information:

Product Information1. Product Name: Ipriflavone

2. Dosage Form: Tablets, capsules, or other relevant forms

3. Strength: Specify the amount of Ipriflavone per serving (e.g., 200 mg, 300 mg)

Usage and Directions1. Recommended Use: Prevent and treat weak bones (osteoporosis) in older women, relieve pain associated with osteoporosis, and treat Paget's disease.

2. Dosage Instructions: Take 1-2 tablets/capsules, 2-3 times a day, or as directed by a healthcare professional.

Safety and Precautions1. Contraindications: Pregnant or breastfeeding women, individuals with known hypersensitivity to Ipriflavone.

2. Warnings: Consult a healthcare professional before use if taking other medications or having underlying medical conditions.

Storage and Handling1. Storage Conditions: Store in a cool, dry place, away from moisture and heat.

2. Shelf Life: 2 years from the date of manufacture.

Regulatory Compliance1. Regulatory Approval: Mention relevant regulatory approvals (e.g., FDA, EMA).

2. Manufacturing Site: Include the name and address of the manufacturing site.

Additional Information1. Mechanism of Action: Briefly describe how Ipriflavone works (e.g., promotes calcium absorption, inhibits bone breakdown).

2. Clinical Benefits: Mention the benefits of using Ipriflavone, such as improved bone density and reduced pain.

Where can Iprifavone Manufactured by MEDIOCON INC are procured?

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

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

For Dosage Forms :

- Online Marketplaces: You can find Iprifavone 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 Iprifavone Manufactured by MEDIOCON INC products.

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