Degradation studies identify how an Active Pharmaceutical Ingredient (API) breaks down under stress conditions (heat, light, humidity, pH, oxidation). This data helps predict shelf life and set expiry dates. These studies support specification setting and control strate gies for various submissions.
PHARMACEUTICAL DEVELOPMENT
Pharmaceutical Development
At Propharmex, pharmaceutical development is a logical, data-driven process, where formulation strategy is based on analysis of bio pharmaceutical properties of the drug substance, Critical Quality Attributes (CQA) and Quality Target Product Profile (QTPP) of the drug product.
- A thorough understanding in pharmaceutical development of various dosage forms and delivery systems in compliance with global regulatory requirements.
- Expertise in working on specific challenges, such as improvement of solubility and bioavailability, release control, targeted delivery and taste masking.
- Well formatted & regulatory compliant documentation
- Submission & Post submission regulatory support
At Propharmex, pharmaceutical development is a logical, data-driven process, where formulation strategy is based on analysis of bio pharmaceutical properties of the drug substance, Critical Quality Attributes (CQA) and Quality Target Product Profile (QTPP) of the drug product.
- A thorough understanding in pharmaceutical development of various dosage forms and delivery systems in compliance with global regulatory requirements.
- Expertise in working on specific challenges, such as improvement of solubility and bioavailability, release control, targeted delivery and taste masking.
- Well formatted & regulatory compliant documentation
- Submission & Post submission regulatory support
Pre-Formulation Studies
A well designed comprehensive study program enable a successful dosage form design and drug delivery.
API Particle Size Distribution and Shape
- Affects dissolution rate and bioavailability of poorly soluble pharmaceutical compounds.
- Controls content uniformity and dose accuracy in final drug products.
- Impacts flowability and compressibility during tablet and capsule manufacturing processes.
Solubility Studies
- Helps in Selection of Drug Form & Choice of salt form or polymorph.
- Helps in excipient selection& enables rational design of formulation strategy.
- Help predict precipitation risks, crystallization, or polymorphic transitions, which canaffect product stability.
- Foundational for developing discriminatory dissolution methods, which are critical for quality control and bioequivalence studies.
Hygroscopicity
- Helps to understand the stability of drug substance & its interaction with excipients.
- Address the Solid dosage form challenges and develop a robust manufacturing process.
- Helps in providing mitigation strategies for manufacturing challenges.
- Helps design the right packaging considerations.
Solid State Characterization
Critical part of pharmaceutical development because the physical form of an active pharmaceutical ingredient (API) or excipient can significantly influence its stability, solubility, dissolution rate, and ultimately bioavailability.
API Degradation Studies
Formulation Development
Oral Solids
Tablets & Capsules
Immediate release/ Modified Release / Osmotic/ Bilayer / Dual Release/ pellets
Oral Liquids
Solutions, suspensions, PFS & Emulsions
Topicals
Dermal, Nasal, Ophthalmic & Otic
Injectables
Solutions, suspensions, PFS & Emulsions
Transdermal Delivery Systems
Gels, Creams and Ointments, Patches
Equipment’s & Instruments:
Equipment(s)
- Vibratory sifter
- High shear mixer granulator
- Fluid bed dryer /processor
- Multi mill & Kalweka multipurpose drive
- Blender(s)
- Compression machine: Bilayer & Multi tooling
- Tablet auto coater & Conventional coating pan
- Ika homogenizer & mixers
- Capsule filling machine
- Blister Packing Machine & Induction sealing
- Transdermal coater
Instruments in IPQC
- UV / visible spectrophotometer
- Halogen moisture balance
- Tablet hardness tester
- pH meter
- Weighing balance(s)
- Tapped density apparatus
- Disintegration tester
- Dissolution apparatus I & II
- Modified USP II Dissolution apparatus (Enhancer cell)
We believe in speed to market is the key to success in generic pharmaceutical industry. Our expertise in Formulation & Analytical Development along with Global Regulatory strong understanding helps Accelerate your New Product Development and Achieve your strategic business objectives.
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