Formulation Development

Kashiv Pharma offers formulation development and preclinical supplies for a full range of pharmaceutical oral dosage forms—from conventional to specialized drug delivery systems. Equipped with fully modernized facilities, our expert team is uniquely positioned to customize formulations for superior product performance, value and differentiation. This includes a cost-effective and robust manufacturing process. Kashiv technologies are suitable for NCE development as well as for product life cycle management.

Key areas of specialization are presented below.

Dosage Forms

  • Tablets and hard gelatin capsules
  • Soft gelatin capsules
  • Liquid fill hard gelatin capsules
  • Oral disintegrating tablets (ODT)
  • Sublingual tablets
  • Buccal tablets
  • Bilayer tablets/Compression coating (tablet-in-tablet)
  • Pellets compressed into tablets

Processes

  • Wet and dry granulations
  • Hot melt extrusion
  • Extrusion and spheronization
  • Fluid bed processing (top spray granulation; drying; Wurster coating)
  • Microfluidization
  • Nano milling
  • Roller compaction

Oral Drug Delivery Platforms

Range from conventional to specialized systems
Controlled or Modified Release
  • Multiparticulates
  • Matrix tablets
  • Programmed drug release (chronotherapeutic approach)
BIOMAXX®

Drug delivery solutions to enhance the oral absorption of poorly bioavailable drug molecules. By the application of in-house technologies, we are able to transform “brick-dust” or “grease ball”-like molecules into innovative medicines, which can:

  • Reduce pill burden
  • Eliminate food effect
  • Reduce PK variability
  • Enhance bioavailability
Fixed Dose Combination Products
  • Bilayer tablet
  • Tablet-in-tablet
  • Powder/pellets/mini-tablets filled into capsules
Bioavailability Enhancement
  • Hot melt Extrusion
  • Nano crystallization (top down and bottom up)
  • Amorphous Oral Disintegrating Tablets
  • Lipid (soft gel) delivery
  • SEDDS, SMEDDS and SNEDDS

Transmucosal Delivery (Sublingual and Buccal)

Pediatric Oral Dosage Forms

Kashiv can provide safe, effective dosage forms that facilitate dosing for a broad pediatric age range and meet all regulatory expectations. Kashiv can also assist in the preparation of Pediatric Investigational Plans (PIPs).

Age-appropriate formulations:

  • Appropriate dose and dosing volumes
  • Appropriate excipients and levels of each
  • Palatable oral formulations
  • Appropriate stability
  • Ease of dosing and patient compliance
  • Dose flexibility while maintaining accuracy and safety

Kashiv offers versatile technologies to address specific needs for pediatric dosage forms:

  • Enhanced bioavailability of poorly soluble drugs resulting in satisfactory exposure
  • Taste masking for bitter drugs (e.g., fine particle coating)
  • ODT resulting in ease-of-swallowing, improving patient compliance
  • Extended release (e.g., ion exchange resin complex)

Pediatric Dosage Forms:

  • Solutions/Syrups/Elixirs
  • Suspensions
  • Powders for Reconstitution as Suspension
  • Dispersible/Effervescent Tablets
  • Chewable Tablets
  • Orally Disintegrating Tablets
  • Tablets/Coated Tablets
  • Sprinkles or Granules (i.e., conventional, fine particle coating for taste masking; extended release: ion exchange resin complex)
  • Capsules