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KMS Pharma

01 — Formulation Development

Formulations designed to survive scale.

A formulation is not a dosage form; it is a set of decisions that either hold at commercial scale or fail there. We define the target product profile and its critical quality attributes first, assess formulation and process risk against the molecule, then use design of experiments to find ranges that stay robust through scale-up, stability and filing.

OutcomePartners receive a formulation and a process that can be manufactured, measured and defended in a dossier.

Oral solid process technologies
9
Oral solid process technologies
Sterile formats developed
15
Sterile formats developed
Design of experiments at every stage
QbD
Design of experiments at every stage
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01

How a formulation programme runs

  1. 01LandscapePatents, literature and compendial requirements reviewed before an excipient is chosen.
  2. 02Target profileThe quality target product profile and critical quality attributes set the goalposts.
  3. 03Risk assessmentFormulation and process risks mapped against the delivery system and the molecule.
  4. 04PreformulationAPI characterisation and drug–excipient compatibility establish what the molecule tolerates.
  5. 05Design of experimentsQbD optimisation finds robust ranges rather than a single working recipe.
  6. 06StabilityDevelopment stability to ICH guidance shows whether those ranges hold over time.
  7. 07Pilot scaleProcess development at pilot scale proves the formulation is manufacturable.

02

Oral solid dosage forms

Tablets, hard and soft gelatin capsules, and powders for oral solution or suspension. The process route is chosen from the molecule’s properties: compressibility, solubility, particle size and stability.

  • Wet granulation
  • Dry granulation (roller compaction)
  • Top-spray granulation
  • Wurster coating
  • Extrusion and spheronisation
  • Multilayer compression
  • Functional and non-functional coating of pellets and tablets
  • Capsule filling
  • API particle-size reduction by air-jet milling

03

Oral liquids and semi-solids

Solutions, suspensions, creams and gels, including reformulations that convert a tablet into an oral liquid for patients who cannot swallow one. Several products in our own differentiated portfolio are built on that route.

  • Oral solutions and suspensions
  • Ready-to-use suspensions
  • Oral concentrates
  • Creams and topical gels

04

Sterile products

Fifteen sterile formats, from aqueous injections to lyophilised products and complex parenteral systems. Container closure, reconstitution behaviour and stability drive the design as much as the API does.

  • Aqueous injections
  • Non-aqueous injections
  • Micro-emulsions
  • Nano-emulsions
  • Nano-suspensions
  • Lyophilised products
  • Pre-filled syringes
  • Infusion bags
  • Ophthalmic solutions
  • Ophthalmic emulsions
  • Ophthalmic suspensions
  • Macro-suspensions
  • Microspheres
  • Liposomes
  • Powders for solution for injection

05

Complex moleculesV-17

Beyond conventional small molecules, we work with the product classes below, and develop biosimilar injections, 505(b)(2) sterile products and NCE clinical formulations.

  • Non-β-lactam products
  • Atypical β-lactams: imipenem, ertapenem, meropenem
  • Protein and peptide products
  • Anti-cancer products
  • Hormone products

06

Drug delivery platforms

Where a conventional dosage form will not deliver the molecule, we apply platform technologies. Self-emulsifying systems address poor oral absorption of lipophilic drugs; orally disintegrating films and wafers remove the need for water; pelletisation with Wurster coating allows enteric and targeted release.

  • Orally disintegrating films (ODF)
  • Orally disintegrating wafers (ODW)
  • Self-emulsifying drug delivery systems (SEDDS)
  • Pelletisation with enteric coating

07

Process equipmentV-24

Development and pilot-scale equipment on site, so formulation decisions are tested on the processes that will make the product.

  • Fluid bed processor with top-spray and Wurster columns (ACG)
  • Roll compactor
  • Extruder and spheroniser (Fuji Paudal)
  • Rotary presses: Cadmach 17-station and Karnavati 10-station, D and B tooling
  • Auto-coater (Neocota) and conventional coating pan
  • Encapsulation machine (MF 300)
  • Air-jet mill and multi mill
  • Octagonal (3 L, 7 L) and double-cone (3 L, 5 L) blenders
  • High-pressure homogeniser (GEA Niro Soavi Panda Plus)
  • Blister packing machine
Next capability02 Analytical Development

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Where does your programme stand?

Tell us the molecule, the dosage form and the market you are filing in. A programme lead will read it and reply with what we would do next.

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Business enquiries: vasanthi@kmshc.com · +91 97898 75194V-23

KMS PharmaChennai