[PHARM 5] Pharmaceutical Development

active pharmaceutical ingredients

active pharmaceutical ingredients

Must be formulated in dosage forms suitable for handling, distribution and administration to patients

pre formulation studies

This refers to the investigations pertaining to various physical and chemical properties of the drug substance

synthetic drugs

are weak acids OR weak bases

solubility dissolution rate stability particle size morphology

issues commonly arising in drug development

solubility

Measured by determining the concentration of the compound in solution after equilibrium

dissolution rate

Rate or speed at which a drug substance dissolves in a medium

high solubility high permeability

class 1

low solubility high permeability

class 2

high solubility low permeability

class 3

low solubility low permeability

class 4

dissolution rate

In drug design, it is intentionally manipulated by including different polymers to produce "slow-release" (for some drugs)

intrinsic solubility molecular weight particle size dispersion of solute

factors affecting dissolution rate

transdermal

highly potent, lipid soluble, low MW

rapid absorption because the mucosa is highly vascularized

competitiveness

• Prevailing policy environment (e.g. Cheaper Medicines Law, labelling requirements, Pharmacy law) is not conducive to industry growth

innovation

• Lack of incentives from the government to both the academe and the pharmaceutical industry to conduct early clinical trials in the country

production and distribution capacity

• Constraints in sourcing API finished products and other supplies

resilience

• Reliance is further aggravated by challenges and increased costs in supply and distribution

• Lack of clear policy to navigate the value chain in times of disasters

ease of doing smooth business

• Smooth business processes are hampered by delays in product registration and licensing

policy development and enhancement short term

• Industry development as one of the pillars in the new Philippine Medicine Policy

• The rate of preferential treatment (currently at 15%) is gradually increased

industry strengthening short term

• 40% of the volume of pharma products being purchased by DOH is supplied by local manufacturers

• Pharmaceutical center at the DOST servicing as a data science hub for the use of the industry and related industries

industry strengthening medium term

• Local manufacturing share in volume of the Philippine Pharmaceutical supplies at 50%

pharma industry support system strengthening short term

· DTI pharma industry expert retention and incentive program · DOH capacity for o Operation health technology assessment (HTA) system o Strengthened procurement and supply chain management system (PSCM) o Improved capacity for forecasting, distribution, and use of value-based metrics

pharma industry support system strengthening medium term

· Mechanisms in PPP for technology transfer and knowledge sharing between local and foreign companies are in place · Investments for health data management are in place · FDA is PIC/S accredited